May 31, 2000 00-22RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Fresh Made Kefir Strawberry-Banana, 32-fluid ounces. Recall #F-461-0. CODE Product shipped between 3/13/00 and 5/1/00 MANFACTURER Fresh Made, Inc., Philadelphia, Pennsylvania. RECALLED BY MANFACTURER. Firm-initiated recall complete. DISTRIBUTION California, Illinois, New Jersey, Pennsylvania. QUANTITY 180 cases (12 per case) were distributed. REASON The Fresh Made Kefir Strawberry-Banana contains undeclared FD&C Yellow No. 5. ________ PRODUCT Shedd's Spread Country Crock Light, in 1-pound tub. Recall #F-463-0. CODE Feb2100TA (located on side of lid) UPC: 27400 22402 (located on side of tub). MANFACTURER Lipton, Dallas, Texas. RECALLED BY Lipton Englewood Cliffs, New Jersey, by letter on September 2, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi, Texas, New Mexico, Oklahoma, Louisiana. QUANTITY 792 cases (18 units per case) were distributed. REASON Product is contaminated with ammonia. ________ PRODUCT Marzipan Candy, packaged in 5-ounce plastic basket containers. Recall #F-464-0. CODE None. MANFACTURER Elk Candy Company, New York, New York. RECALLED BY Manufacturer, by letter on November 16, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Firm estimates none remains on the market. REASON Product contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1 and FD&C Red No. 3. In addition, the product contains an unapproved color additive formerly certifiable as FD&C Red No. 2. ________ PRODUCT Jiang Tang brand Ginger Flavor Candy, in 8.8-ounce flexible plastic bags. Product of China. Recall #F-465-0. CODE None. MANFACTURER Guangdong Jiangmen Foreign Trade Development Corporation, Jiangmen, Guangdong, China. RECALLED BY 282 International Trading Inc., Brooklyn, New York, by telephone on November 4, 1999. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 100 cases (24 bags per case) were distributed. REASON Product contained the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT El Jugoso - La Hacienda brand Pan - Bread in 6-ounce flexible plastic packages. Recall #F-466-0. CODE All product on the market at time of recall initiation. MANFACTURER Hacienda Products, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by telephone on June 14, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 600 packages were distributed. Because the product only has a 15-day shelf life, none is expected to remain on the market. REASON Product contained undeclared FD&C Yellow No. 5. ________ PRODUCT Philadelphia Candies Milk Chocolate Fruits and Nuts, in 1-pound box. Recall #F-469-0. CODE All products distributed since January 1, 2000 to May 3, 2000. MANFACTURER Philadelphia Candies, Inc., Hermitage, Pennsylvania. RECALLED BY Manufacturer, by telephone on May 3, 2000, and provided a placard with correct labeling information. Firm-initiated recall (relabeling) ongoing. DISTRIBUTION Pennsylvania and Ohio. QUANTITY Firm estimated that 30 1-pound containers remained on market at time of recall initiation. REASON The chocolate covered pineapple product contains undeclared FD&C Yellow No. 5, and the chocolate covered cherry product contains undeclared FDC Red No. 40. ________ PRODUCT Pineapple Chunks packed in natural juice, in 108-ounce (6-pound 12-ounce) containers. Recall #F-470-0. CODE All can codes with a top line of 108912. MANFACTURER Summerpride Foods, Inc., East London, South Africa. RECALLED BY Sunlight Foods, Inc., Miami, Florida, by letter on April 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida. QUANTITY 782 cases (6 cans per case) were distributed. REASON Product contains elevated levels of tin. _______ UPDATE Recall #F-439/449, White and parboiled rice manufactured by AC Humko Rice Specialties, which appeared in the May 17, 2000 Enforcement Report is being updated to include bulk parboiled rice manufactured from 2/26/00-3/3/00 and bulk white rice manufactured from 2/11/00-3/3/00.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Purity brand Syrup, in 24-fluid ounce plastic bottles. Recall #F-462-0. CODE Lot Numbers: 9091, 11700, 11800, 11900, 16600, 16700, 16800, 18600, 18700, 18800, 18900, 29100, 29200, and 29300. MANFACTURER Nealanders International, Mississauga, Ontario, Canada. RECALLED BY Purity Foods, Inc., Clayton, Ohio (distributor), by fax and mail on April 26, 2000. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Minnesota, Pennsylvania, California, New York, Michigan, Minnesota, Rhode Island, Ohio. QUANTITY Approximately 6,000 (12 bottles per case) cases were distributed. REASON Product does not meet the standard of identify for table syrup as specified in 21 CFR 168.180 because it did not contain the required amount of soluble sweetener solids. ________ PRODUCT 8" Single Layer Carrot Cake w/Creme Cheese Frosting (frozen), packed in rigid plastic containers (8 inch/25 ounce). Recall #F-467-0. CODE All products manufactured up to 4/25/00. MANFACTURER LaBree's Bakery, Old Towne, Maine. RECALLED BY Manufacturer, by telephone on April 26, 2000. Firm-initiated field correction (relabeling) ongoing. DISTRIBUTION Massachusetts, New Jersey, New York, Ohio, Pennsylvania. QUANTITY Approximately 950 cases (packed 6 x 25-ounce cake) were distributed from 4/10/00 to 4/25/00. REASON Product contains undeclared FD&C Blue No. 1RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Afassco brand Alcohol Prep Pad, 70% Isopropyl Alcohol USP, antiseptic wipes, 24 swabs and 100 swabs per box. Recall #D-353-0. CODE Order #626 and 2626, All lot codes. MANFACTURER Afassco, Carson City, Nevada. RECALLED BY Manufacturer, by letter mailed beginning on March 24, 2000, followed by telephone. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Charlotte, North Carolina. DISTRIBUTION Nationwide. QUANTITY 282,528 units were distributed. REASON Lack of assurance of sterility on product received from Clinipad Corporation. ________ PRODUCT a) Albuterol, USP inhalation Aerosol,17 g, 200 metered inhalations: Proventil Aerosol Inhaler 90MCG Per Actuation 17G Canister, NDC 0885-0614-02; Proventil Inhalation Aerosol (Refill) 90 MCG 17G Canister NDC 0885-0614-03; Albuterol USP Inhalation Aerosol 90MCG 17G Canister Warrick NDC 9930-1560-01; Albuterol USP Inhalation Aerosol 90MCG 17G Canister Refill Warrick NDC 9930-1560-02. Private Labels: Martec NDC 5255-5594-17, 5255-5594-18 (refill); Major NDC 0904-5078-34 and NDC 0904-5078-68 (refill); Qualitest NDC 0603-1004-75; Novopharm NDC 5595-3051-53 and 5595-3501-01 (refill); Schein NDC 0364-2632-98; United Research Laboratory NDC #0671-1549-70. b) Vanceril Double Strength Inhalation Aerosol (beclomethasone dipropionate), 84 mcg, 40 (5.4 g) and 120 (12.2g) metered inhalations, Rx for maintenance treatment of asthama. (NDC 0085-1112-01 and NDC 0085-1112-03) c) Vanceril Inhalation Aerosol (beclomethasone dipropionate), 42 mcg, 80 (6.7 g) and 200 (16.8g) metered inhalations, Rx, for maintenance treatment of asthma (NDC #0085-0736-04 and 0085-0738-12) d) Vancenase POCKETHALER® Nasal Aerosol, (beclomethasone dipropionate), 42 mcg, 200 (7g) metered doses, Rx indicated for the relief of the symptoms of seasonal or perennia rhinitis. (NDC #0085-0649-02) e) Vancenase Nasal Aerosol, (beclomethasone dipropionate), 42 mcg, 200 (16.8g) metered doses, Rx indicated for the relief of the symptoms of seasonal or perennia rhinitis. (NDC #0085-0041-16) Recall #D-369/373-0. CODE PROVENTIL/ALBUTEROL INHALERS BATCH EXPIRATION DATE 7-BBS-303 03/31/00 7-BBS-600 03/31/00 7-BBS-601 03/31/00 7-BBS-602 03/31/00 7-BBS-603 03/31/00 7-BBS-604 03/31/00 7-BBS-605 03/31/00 7-BBS-606 03/31/00 7-BBS-607 03/31/00 7-BBS-608 03/31/00 7-BBS-609 03/31/00 7-BBS-610 03/31/00 7-BBS-611 03/31/00 7-BBS-612 04/30/00 7-BBS-613 04/30/00 7-BBS-614 04/30/00 7-BBS-617 04/30/00 7-BBS-618 04/30/00 7-BBS-619 04/30/00 7-BBS-620 04/30/00 7-BBS-621 04/30/00 7-BBS-622 04/30/00 7-BBS-623 05/31/00 7-BBS-624 05/31/00 7-BBS-625 05/31/00 7-BBS-626 05/31/00 7-BBS-627 05/31/00 7-BBS-628 05/31/00 7-BBS-629 05/31/00 7-BBS-630 05/31/00 7-BBS-631 05/31/00 7-BBS-632 05/31/00 7-BBS-633 06/30/00 7-BBS-634 06/30/00 7-BBS-635 06/30/00 7-BBS-636 06/30/00 7-BBS-637 06/30/00 7-BBS-638 06/30/00 7-BBS-639 06/30/00 7-BBS-640 06/30/00 7-BBS-641 06/30/00 7-BBS-642 06/30/00 8-BBS-500 07/31/00 8-BBS-501 07/31/00 8-BBS-502 07/31/00 8-BBS-503 07/31/00 8-BBS-505 07/31/00 8-BBS-506 07/31/00 8-BBS-507 07/31/00 8-BBS-508 07/31/00 8-BBS-509 07/31/00 8-BBS-510 07/31/00 8-BBS-511 08/31/00 8-BBS-512 08/31/00 8-BBS-613 08/31/00 8-BBS-514 08/31/00 8-BBS-515 08/31/00 8-BBS-516 08/31/00 8-BBS-517 08/31/00 8-BBS-518 08/31/00 8-BBS-519 08/31/00 8-BBS-520 08/31/00 8-BBS-521 08/31/00 8-BBS-522 08/31/00 8-BBS-523 08/31/00 8-BBS-524 08/31/00 8-BBS-526 09/30/00 8-BBS-527 09/30/00 8-BBS-528 09/30/00 8-BBS-529 09/30/00 8-BBS-530 09/30/00 8-BBS-531 09/30/00 8-BBS-532 09/30/00 8-BBS-533 09/30/00 8-BBS-534 09/30/00 8-BBS-535 09/30/00 8-BBS-536 09/30/00 8-BBS-537 09/30/00 8-BBS-538 09/30/00 8-BBS-539 09/30/00 8-BBS-540 09/30/00 8-BBS-541 09/30/00 8-BBS-542 10/31/00 8-BBS-543 10/31/00 8-BBS-544 10/31/00 8-BBS-545 10/31/00 8-BBS-546 10/31/00 8-BBS-547 10/31/00 8-BBS-548 10/31/00 8-BBS-549 10/31/00 8-BBS-550 10/31/00 8-BBS-551 10/31/00 8-BBS-552 10/31/00 8-BBS-553 10/31/00 8-BBS-555 11/30/00 8-BBS-556 11/30/00 8-BBS-557 11/30/00 8-BBS-559 11/30/00 8-BBS-560 11/30/00 8-BBS-561 11/30/00 8-BBS-562 11/30/00 8-BBS-563 11/30/00 8-BBS-564 11/30/00 8-BBS-565 11/30/00 8-BBS-566 12/31/00 8-BBS-567 12/31/00 8-BBS-568 12/31/00 8-BBS-569 12/31/00 8-BBS-570 12/31/00 8-BBS-571 12/31/00 8-BBS-572 12/31/00 8-BBS-573 12/31/00 8-BBS-574 12/31/00 8-BBS-575 12/31/00 8-BBS-576 12/31/00 8-BBS-577 12/31/00 8-BBS-578 12/31/00 8-BBS-579 01/31/01 8-BBS-580 01/31/01 8-BBS-581 01/31/01 8-BBS-582 01/31/01 8-BBS-583 01/31/01 8-BBS-584 01/31/01 8-BBS-585 01/31/01 8-BBS-586 01/31/01 8-BBS-587 01/31/01 8-BBS-588 01/31/01 8-BBS-589 02/28/01 8-BBS-590 02/28/01 8-BBS-591 02/28/01 8-BBS-592 02/28/01 8-BBS-593 02/28/01 8-BBS-594 02/28/01 8-BBS-595 02/28/01 8-BBS-596 02/28/01 8-BBS-597 02/28/01 8-BBS-598 02/28/01 8-BBS-599 03/31/01 8-BBS-600 03/31/01 8-BBS-601 03/31/01 8-BBS-602 03/31/01 8-BBS-603 03/31/01 8-BBS-604 03/31/01 8-BBS-605 03/31/01 8-BBS-606 03/31/01 8-BBS-607 10/31/00 8-BBS-609 04/30/01 8-BBS-610 04/30/01 8-BBS-611 04/30/01 8-BBS-612 04/30/01 8-BBS-613 04/30/01 8-BBS-614 04/30/01 8-BBS-615 04/30/01 8-BBS-620 05/31/01 8-BBS-621 05/31/01 8-BBS-622 05/31/01 8-BBS-635 06/30/01 8-BBS-636 06/30/01 8-BBS-638 06/30/01 8-BBS-639 06/30/01 8-BBS-640 06/30/01 8-BBS-641 06/30/01 8-BBS-642 06/30/01 8-BBS-643 06/30/01 8-BBS-644 06/30/01 8-BBS-645 07/31/01 8-BBS-646 07/31/01 8-BBS-800 10/31/00 8-BBS-801 10/31/00 8-BBS-802 10/31/00 8-BBS-803 10/31/00 8-BBS-804 10/31/00 8-BBS-805 11/30/00 8-BBS-806 11/30/00 8-BBS-807 11/30/00 8-BBS-808 11/30/00 8-BBS-809 12/31/00 8-BBS-810 01/31/01 8-BBS-811 01/31/01 8-BBS-812 01/31/01 8-BBS-813 01/31/01 8-BBS-814 02/28/01 8-BBS-815 02/28/01 8-BBS-816 02/28/01 8-BBS-817 02/28/01 8-BBS-818 03/31/01 8-BBS-819 03/31/01 8-BBS-820 03/31/01 8-BBS-821 03/31/01 8-BBS-822 06/30/01 8-BBS-823 06/30/01 8-BBS-824 06/30/01 8-BBS-825 06/30/01 8-BBS-826 07/31/01 9-BBS-500 07/31/01 9-BBS-501 07/31/01 9-BBS-502 07/31/01 9-BBS-503 07/31/01 9-BBS-504 07/31/01 9-BBS-505 07/31/01 9-BBS-506 07/31/01 9-BBS-507 07/31/01 9-BBS-508 07/31/01 9-BBS-509 07/31/01 9-BBS-510 07/31/01 9-BBS-511 08/31/01 9-BBS-512 08/31/01 9-BBS-513 08/31/01 9-BBS-514 08/31/01 9-BBS-515 08/31/01 9-BBS-516 08/31/01 9-BBS-517 08/31/01 9-BBS-518 08/31/01 9-BBS-519 08/31/01 9-BBS-520 08/31/01 9-BBS-521 08/31/01 9-BBS-522 08/31/01 9-BBS-523 08/31/01 9-BBS-524 08/31/01 9-BBS-525 08/31/01 9-BBS-529 09/30/01 9-BBS-530 09/30/01 9-BBS-531 09/30/01 9-BBS-532 09/30/01 9-BBS-533 09/30/01 9-BBS-534 09/30/01 9-BBS-535 09/30/01 9-BBS-536 09/30/01 9-BBS-537 09/30/01 9-BBS-538 09/30/01 9-BBS-539 09/30/01 9-BBS-540 03/31/01 9-BBS-541 09/30/01 9-BBS-542 03/31/01 9-BBS-543 04/30/01 9-BBS-544 04/30/01 9-BBS-545 04/30/01 9-BBS-546 04/30/01 9-BBS-547 04/30/01 9-BBS-548 04/30/01 9-BBS-549 04/30/01 9-BBS-550 04/30/01 9-BBS-551 04/30/01 9-BBS-552 04/30/01 9-BBS-553 04/30/01 9-BBS-554 04/30/01 9-BBS-555 04/30/01 9-BBS-556 04/30/01 9-BBS-557 05/31/01 9-BBS-558 05/31/01 9-BBS-559 05/31/01 9-BBS-560 05/31/01 9-BBS-561 05/31/01 9-BBS-562 05/31/01 9-BBS-563 05/31/01 9-BBS-564 05/31/01 9-BBS-565 05/31/01 9-BBS-566 05/31/01 9-BBS-567 05/31/01 9-BBS-568 05/31/01 9-BBS-569 05/31/01 9-BBS-570 05/31/01 9-BBS-571 06/30/01 9-BBS-572 06/30/01 9-BBS-573 06/30/01 9-BBS-574 06/30/01 9-BBS-575 06/30/01 9-BBS-576 06/30/01 9-BBS-578 06/30/01 9-BBS-579 06/30/01 9-BBS-580 06/30/01 9-BBS-581 06/30/01 9-BBS-582 07/31/01 9-BBS-583 07/31/01 9-BBS-584 07/31/01 9-BBS-585 07/31/01 9-BBS-586 07/31/01 9-BBS-587 07/31/01 9-BBS-588 07/31/01 9-BBS-589 07/31/01 9-BBS-590 07/31/01 9-BBS-591 07/31/01 9-BBS-592 07/31/01 9-BBS-593 07/31/01 9-BBS-594 08/31/01 9-BBS-595 08/31/01 9-BBS-596 08/31/01 9-BBS-597 08/31/01 9-BBS-598 08/31/01 9-BBS-599 08/31/01 9-BBS-600 08/31/01 9-BBS-601 08/31/01 9-BBS-602 08/31/01 9-BBS-603 08/31/01 9-BBS-604 08/31/01 9-BBS-605 08/31/01 9-BBS-606 08/31/01 9-BBS-607 08/31/01 9-BBS-608 08/31/01 9-BBS-609 08/31/01 9-BBS-610 09/30/01 9-BBS-611 09/30/01 9-BBS-612 09/30/01 9-BBS-613 09/30/01 9-BBS-614 09/30/01 9-BBS-615 09/30/01 9-BBS-616 09/30/01 9-BBS-617 09/30/01 9-BBS-618 09/30/01 9-BBS-619 09/30/01 9-BBS-620 09/30/01 9-BBS-621 09/30/01 9-BBS-622 09/30/01 9-BBS-623 09/30/01 9-BBS-800 07/31/01 9-BBS-801 07/31/01 9-BBS-802 07/31/01 9-BBS-803 07/31/01 9-BBS-804 07/31/01 9-BBS-805 07/31/01 9-BBS-806 07/31/01 9-BBS-807 07/31/01 9-BBS-808 08/31/01 9-BBS-809 08/31/01 9-BBS-810 08/31/01 9-BBS-811 02/28/01 9-BBS-815 03/31/01 9-BBS-816 04/30/01 9-BBS-817 04/30/01 9-BBS-818 04/30/01 9-BBS-819 04/30/01 9-BBS-820 04/30/01 9-BBS-821 07/31/01 9-BBS-822 07/31/01 9-BBS-823 07/31/01 9-BBS-824 07/31/01 9-BBS-825 07/31/01 9-BBS-826 07/31/01 9-BBS-827 08/31/01 9-BBS-828 08/31/01 9-BBS-829 08/31/01 9-BBS-830 08/31/01 9-BBS-831 08/31/01 9-BBS-832 08/31/01. VANCERIL INHALER (AMA) -- BATCH EXPIRATION DATE 8-AMA-208.03/31/00 8-AMA-209.03/31/00 8-AMA-210.03/31/00 8-AMA-211.03/31/00 8-AMA-212.09/30/00 8-AMA-213.09/30/00 8-AMA-214.09/30/00 8-AMA-215.10/31/00 8-AMA-216.10/31/00 8-AMA-217.10/31/00 8-AMA-219.11/30/00 8-AMA-220.11/30/00 8-AMA-221.11/30/00 8-AMA-222.11/30/00 8-AMA-408.04/30/00 8-AMA-409.04/30/00 8-AMA-410.04/30/00 8-AMA-600.09/30/00 8-AMA-701.06/30/00 8-AMA-702.06/30/00 8-AMA-703.09/30/00 9-AMA-200.02/28/01 9-AMA-201.02/28/01 9-AMA-202.02/28/01 9-AMA-203.02/28/01 9-AMA-204.03/31/01 9-AMA-205.03/31/01 9-AMA-206.03/31/01 9-AMA-207.03/31/01 9-AMA-208.04/30/01 9-AMA-209.04/30/01 9-AMA-210.04/30/01 9-AMA-211.04/30/01 9-AMA-212.04/30/01 9-AMA-213.05/31/01 9-AMA-214.05/31/01 9-AMA-215.05/31/01 9-AMA-216.05/31/01 9-AMA-217.07/31/01 9-AMA-218.07/31/01 9-AMA-219.07/31/01 9-AMA-220.07/31/01 9-AMA-221.07/31/01 9-AMA-222.07/31/01 9-AMA-223.09/30/01 9-AMA-225.09/30/01 9-AMA-226.09/30/01 9-AMA-227.09/30/01 9-AMA-228.09/30/01 9-AMA-401.02/28/01 9-AMA-402.02/28/01 9-AMA-403.03/31/01 9-AMA-404.03/31/01 VANCERIL DOUBLE STRENGTH INHALER BATCH EXPIRATION DATE 8-DMT-644 03/31/00 8-DMT-646 03/31/00 9-DMT-133 03/31/00 9-DMT-134 03/31/00 9-DMT-135 03/31/00 9-DMT-136 03/31/00 9-DMT-137 03/31/00 9-DMT-139 05/31/00 9-DMT-140 05/31/00 9-DMT-141 05/31/00 9-DMT-142 05/31/00 9-DMT-143 05/31/00 9-DMT-144 05/31/00 9-DMT-145 05/31/00 9-DMT-146 05/31/00 9-DMT-147 05/31/00 9-DMT-148 05/31/00 9-DMT-149 05/31/00 9-DMT-150 05/31/00 9-DMT-151 05/31/00 9-DMT-152 05/31/00 9-DMT-153 05/31/00 9-DMT-154 05/31/00 9-DMT-155 05/31/00 9-DMT-156 05/31/00 9-DMT-157 07/31/00 9-DMT-158 07/31/00 9-DMT-160 07/31/00 9-DMT-161 07/31/00 9-DMT-163 07/31/00 9-DMT-600 07/31/00 9-DMT-601 07/31/00 9-DMT-608 08/31/00 9-DMT-610...10/31/00 9-DMT-616 11/30/00 9-DMT-617 11/30/00 9-DMT-618 11/30/00 9-DMT-619 11/30/00 9-DMT-620 11/30/00 9-DMT-621 11/30/00 VANCENASE POCKETHALER (RRG) BATCH EXPIRATION DATE 8-RRG-113...04/30/00 8-RRG-114...04/30/00 8-RRG-115...04/30/00 8-RRG-116...04/30/00 8-RRG-117...05/31/00 8-RRG-118.. 05/31/00 8-RRG-119...05/31/00 8-RRG-120...05/31/00 8-RRG-121...05/31/00 9-RRG-101 09/30/00 9-RRG-103...09/30/00 9-RRG-104 09/30/00 9-RRG-107 11/30/00 9-RRG-109...11/30/00 9-RRG-110...11/30/00 9-RRG-111... 12/31/00 9-RRG-112...12/31/00 9-RRG-113...12/31/00 9-RRG-114... 03/31/01 9-RRG-116...03/31/01 9-RRG-117...03/31/01 9-RRG-118... 03/31/01 9-RRG-119...03/31/01 VANCENASE NASAL INHALER (AMA) BATCHEXPIRATION DATE 8-AMA-600 09/30/00 9-AMA-100.02/28/01. MANFACTURER Schering Laboratories, Kenilworth, New Jersey. RECALLED BY Manufacturer, by fax on March 29, 2000, mailgram on March 30, 2000, and by letters April 1-4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Canada. QUANTITY Proventil/Albuterol inhalers: 58,936,179 units Vanceril 84 mcg: 831,594 units Vanceril 42 mcg: 5,274,819 units Vancenase: 2,706,425 units were distributed. REASON Some canisters may not have active ingredient. ________ PRODUCT Vira-A(r) Ophthalmic Ointment, USP 3%, (Vidarabine), in 3.5 gram tubes, Rx. NDC #61570-367-71 (1 tube carton) and NDC 61570-367-72 (12 tube carton). Recall #D-374-0. CODE Lot #5739 EXP 01/02. MANFACTURER Parkedale Pharmaceuticals, Inc., A wholly owned subsidiary of King Pharmaceuticals, Rochester, Michigan. RECALLED BY King Pharmaceuticals, Inc., Bristol, Tennessee, by letter dated April 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 38,704 tubes were distributed. REASON Leaking tubes at crimp end. ________ PRODUCT Caverject(r) Injection, Rx for intravernosal use only: a) Caverject(r) Injection (alprostadil 20mcg), NDC #0009-3701-01 b) Caverject(r) Injection (alprostadil 10mcg), NDC #0009-3778-08 c) Caverject(r) Injection (alprostadil 5mcg), NDC #0009-7212-03 d) Companion pack for Caverject(r) Injection (alprostadil), Rx contains 5 companion packs. Each companion pack contains 2 sterile needles, 1-2 ml sterile syringe assembly and 1 alcohol swab. Recall #D-375/378-0. CODE All lot numbers. MANFACTURER Pharmacia & Upjohn, Kalamazoo, Michigan. Anajay, Inc., Charlotte (name on alcohol swabs). RECALLED BY Pharmacia & Upjohn, Kalamazoo, Michigan, by letter dated Mach 31, 2000. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Lack of assurance of sterility with alcohol preps manufactured by the Clinipad Company, packaged with Caverject(r) product. ________ PRODUCT Solu-Medrol Methylprednisolone Sodium Succinate for Injection, USP, 125 mg, Act-O-Vial(r) single dose vial, 2mL, Rx sterile powder. Recall #D-379-0. CODE Lot #50DHD EXP 7/31/02. MANFACTURER Pharmacia & Upjohn, Kalamazoo, Michigan. RECALLED BY Manufacturer, by letter dated February 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 5,252 cartons of 25 vials each were distributed. REASON Lack of assurance of sterility. ________ PRODUCT Methadose(r) (Methadone Hydrochloride Oral Concentrate, USP), 10mg/mL, in 1 quart bottles, Rx for detoxification and maintenance treatment for narcotic addiction. NDC#0406-0527-05. Recall #D-380-0. CODE Lot #B01461 EXP 02/01. MANFACTURER Mallinckrodt, Inc., St. Louis, Missouri. RECALLED BY Manufacturer, by telephone, fax and certified mail on May 2, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 1,060 bottles were distributed. REASON Superpotency. ________ PRODUCT a) Zilatone Laxative Tablets, (Phenolphthalein 32 mg per tablet), OTC in 50 tablet bottles; b) Zilatone Laxative Digestive Aid Tablets, Phenolphthalein 32 mg per tablet), OTC in 50 tablet bottles. Recall #D-381/382-0. CODE a) All lots with expiration dates from EXP OCT 01 to EXP JUN 02 b) All lots with expiration dates prior to EXP OCT 01. MANFACTURER Abco Laboratories, Inc., Fairfield, California. RECALLED BY The Heritage Store, Inc., Virginia Beach, Virginia, by telephone beginning on March 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,227 units were distributed; firm estimated that 20 units remained on market at time of recall initiation. REASON Products contain phenolphthalein which is not generally recognized as safe and effective in over-the-counter stimulant laxatives. ________ PRODUCT Prep-Clean Kits, containing sterile antiseptic pads, used for cleaning and disinfecting cartridge type, full-face and helmet respirators utilized by industry. Sterile prep pads included in the kits are labeled as Clinipad Corporation, Charlotte, NC, coded NDC-19154-1245-8, Reorder code 0250B, Lot 819178. Recall #D-383-0. CODE Kit Numbers: PC333, PC444, PC555, PC777. MANFACTURER Georgia Steel and Chemical Company, Annapolis Junction, Maryland. RECALLED BY Manufacturer, by letter on March 29, 2000. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Maryland, Pennsylvania, Wisconsin, Kentucky, Texas, Louisiana, Indiana, Tennessee, Florida, Missouri, Colorado. QUANTITY 936 kits were distributed. REASON Cleaning kits contain alcohol pads for which the pad manufacturer (Clinipad Company)cannot assure sterility. ________ PRODUCT Oxygen, USP, Compressed, in size D cylinders. Recall #D-384-0. CODE Lot #042105 EXP 4/21/05. MANFACTURER Home Nursing Care, Inc., doing business as Community Home Care Services, Richlands, Virginia. RECALLED BY Manufacturer, by visit on April 24, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 2 cylinders were distributed. REASON Current good manufacturing deviations including but not limited to document pre-fill, fill and post fill operations. ________ PRODUCT VioNex Antimicrobial skin wipe towelette, (0.5% Parachlorometaxylenol), OTC used to clean skin when soap and water are not available. NDC #55443-0102-1. Recall #D-385-0. CODE Lot Numbers: 903193, 911283, 912850, and 913598. MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. RECALLED BY Sybron Dental Specialties, Inc., Orange, California, by letter on March 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Canada. QUANTITY 2,481.4 cases (10 units per case) of all lots were distributed. REASON Towelettes manufacturer (Clinipad Company) cannot assure product meets microbial release specifications. ________ PRODUCT Promethazine Syrup Plain, 6.25 mg/5mL in 4 and 16 ounce bottles, Rx for the treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic reaction, sedation in both children and adults, and antiemetic therapy in posoperative patients, packaged under the MGP (NDC #60432-608-16) and Major Pharmaceuticals (NDC#0904-1508-16) labels. Recall #D-390-0. CODE Lot Numbers: 22086A, 22086C, 22086E. MANFACTURER Morton Grove Pharmaceuticals, Morton Grove, Illinois. RECALLED BY MANFACTURER, by letter dated May 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 7,224 4-ounce and 1,536 16-ounce bottles were distributed. REASON Subpotency (at stability testing).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Allegra-D Extended-Release Tablets, (Fexofenadine HCL 60 mg and Pseudoephedrine HCL 120 mg), in 100 tablet bottles, Rx. DC #0088-1090-47. Recall #D-386-0. CODE Lot #1017145 EXP 6/01. MANFACTURER Aventis Pharmaceuticals, Inc., Kansas City, Missouri. RECALLED BY Manufacturer, by letter dated January 18, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 12,556 bottles were distributed. REASON Expiration date incorrectly declared (June 2001 instead May 2001). ________ PRODUCT Roberts Pharmaceuticals brand Entuss-D liquid Antitussive, nasal decongestant, expectorant. 16 fl. Oz. NDC 54092-438-16. Rx Control Schedule III. Contains hydrocodone bitartrate 5 mg., pseudoephedrine hydrochloride 30 mg., potassium guaiacolsulfonate 300 mg per 5 ml. Recall #D-387-0. CODE Lot M78280 EXP 12/00. MANFACTURER Schwarz Pharma Manufacturing, Inc., Seymour, Indiana. RECALLED BY Manufacturer, by letter on January 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION California and New Jersey. QUANTITY 3,344 bottles were distributed. REASON Subpotent (24 month stability). ________ PRODUCT NeGram Suspension (Nalidixic Acid Oral Suspension, USP), 250 mg/5mL, in 1 pint bottles, Rx indicated for the treatment of urinary tract infections. NDC #0024-1318-06. Recall #D-388-0. MANFACTURER Bayer Corporation, Myerstown, Pennsylvania. RECALLED BY Sanofi Pharmaceutical, Inc., New York, by letter on April 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 1,200 units were distributed; firm estimated that 60 units remained on market at time of recall initiation. REASON Superpotent (at stability - 12 months). ________ PRODUCT Zantac (Ranitidine Tablets), 75 mg, 4 tablet units, OTC acid reducer. NDC #0501-5200-04. Recall #D-389-0. CODE Lot #8ZP1066 EXP 06/01. UPC 3-12547-68404-0. MANFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina. RECALLED BY The Consumer Healthcare Division of Warner-Lambert Company, Morris Plains, New Jersey, by letter on April 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10,924 cases were distributed. REASON Product fails appearance of specification due to container/packaging deviation. ________ PRODUCT Promethazine with Codeine Cough Syrup, 6.25 mg/5mL and 10 mg/5mL, in 4-fluid ounce bottles, Rx for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold under the MGP label label NDC #60432-606-04. Recall #D-391-0. CODE Lot #22649A. MANFACTURER Morton Grove Pharmaceuticals, Morton Grove, Illinois. RECALLED BY Manufacturer, by letter dated May 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 4,128 bottles were distributed. REASON Subpotency (at stability testing). ________ PRODUCT Cefuroxime for Injection USP, 7.5 mg, IM/IV use, pharmacy bulk package for preparing IV admixtures, Rx. NDC #59772-6569-1. Recall #D-392-0. CODE C2424 EXP 6/01, C2522 EXP 11/01, C2562 EXP 3/02. MANFACTURER Bristol-Myers Squibb Company, Princeton, New Jersey (own label distributor). RECALLED BY G.C. Hanford Mfg. Company, Syracuse, New York, by letter dated May 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Illinois, Louisiana, Massachusetts, Missouri, Minnesota, Mississippi, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas, Utah, Washington state, Wisconsin, West Virginia, international. QUANTITY 9,150 vials of lot C2424 and 8,870 vials of lot C2522 were distributed. None of lot C8760 left the control of Bristol-Myers Squibb. REASON Mislabeling - Back panel of carton incorrectly declares 750 mg of Cefuroxime activity per mL instead of the correct per 8mL.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Red Blood Cells, Leukoreduced. Recall #B-661-0. CODE Unit #21KJ25028. MANFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letter dated January 5, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. __________ PRODUCT Platelets, Pheresis. Recall #B-662-0. CODE Unit #6024801. MANFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on January 25, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON A unit of platelets, pheresis, equivalent to five random platelet units was labeled as equal to ten random platelet units. ________ PRODUCT Cryoprecipitated AHF. Recall #B-667-0. CODE Unit #21KL17720. MANFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on February 8, 2000, and by letter dated February 18, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted red blood cells. ________ PRODUCT Platelets. Recall #B-668-0. CODE Unit #13GM3342. MANFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated July 19, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted red blood cells. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-690/691-0. CODE Unit #53GM23433. MANFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated December 16, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had taken the drug Evista. ________ PRODUCT SoftBank LIS or Softbank Laboratory Information System. Recall #B-692-0. CODE All versions installed in computer systems. MANFACTURER Soft Computer Consultants, Palm Harbor, Florida. RECALLED BY Manufacturer, by letters dated February 28, 2000, followed by visit. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 85 units were distributed. REASON There is no way of assuring that ADT-Interface transactions will always include correct patient data. ________ PRODUCT Platelets. Recall #B-701-0. CODE Unit #12443-3571. MANFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 25, 2000. Firm-initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who took aspirin within 3 days of collection. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-702/704-0. CODE Unit Numbers: 01GE03346, 01GW01309: b) 01GW01309: c) 01GE03346, 01GW01309. MANFACTURER American Red Cross Blood Services, Albany, New York. RECALLED BY Manufacturer, by letters dated August 2, 1999, and dated September 10, 1999, or July 30, 1999. Firm-initiated recall complete. DISTRIBUTION New York, California, and Switzerland. QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed. REASON Blood products which tested negative for anti-HCV, but were collected from a donor who previously tested reactive for anti-HCV, RIBA indeterminate.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______ PRODUCT Platelets. Recall #B-663-0. CODE Unit #01LH24264. MANFACTURER American Red Cross Blood Services, Buffalo, New York. RECALLED BY Manufacturer, by letter dated May 19, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood which was designated as a slow bleed. ________ PRODUCT Platelets. Recall #B-664-0. CODE Unit #01FF10945. MANFACTURER American Red Cross Blood Services, Binghampton, New York. RECALLED BY Manufacturer, by letter dated September 18, 1998. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented. ________ PRODUCT Red Blood Cells. Recall #B-669-0. CODE Unit #38K74782. MANFACTURER American Red Cross, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone on January 14, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cells, Irradiated. Recall #B-671-0. CODE Unit numbers: 35FC27957, 35FH41684. MANFACTURER American Red Cross, Roanoke, Virginia. RECALLED BY Manufacturer, by letter dated February 11, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT a) Platelets; b) Fresh Frozen Plasma. Recall #B-696/697-0. CODE Unit numbers: a) 6306913, 9807636, 4316652, 4411724, 2424148, 2212789; b) 6306913, 2424148. MANFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by telephone between November 1 and 4, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY a) 6 units; b) 2 units were distributed. REASON Blood products were prepared from units of whole blood with extended collection times. ________ PRODUCT Platelets. Recall #B-698-0. CODE Unit #26158-8490. MANFACTURER United Blood Services, Texarkana, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 21, 1999. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. ________ PRODUCT Red Blood Cells. Recall #B-721-0. CODE Unit #02FQ00767. MANFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on September 9, 1998. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving information concerning a post donation illness.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______ PRODUCT All Clini-Kits and COBE Clinical Kits containing Antiseptic Products recalled by Clinipad Corporation. Recall #Z-687-0. CODE All lot numbers of the following product codes manufactured by GAMBRO Healthcare, 1990 Industrial Drive, DeLand, Florida, within the last 3 years. All product codes begin with 014108 followed by: 0010C-0012C, 0014C, 0017C, 0019C-0021C, 0024C, 0025C, 0027C, 0028C, 0037C-0040C, 0043C-0045C, 0047C-0051Cl, 0053C, 0056C-0060C, 0062C, 0065C, 0066C, 0068C-0070C, 0072C, 0074C-0076C, 0079C-0083C, 0088C, 0091C-0095C, 0098C-0100C, 0102C, 0103C, 0105C, 0107C, 0109C, 0110C, 0111C, 0114C, 0115C, 0122C-0124C, 0126C, 0128C-0131C, 0133C-0135C, 0137C, 0145C, 0146C, 0150C-0153C, 0155C-0161C, 0164C, 0166C-0193C, 0201C-0203C, 0205C, 0208C, 0209C, 0211C, 0213C-0231C, 0233C-0236C, 0238C, 0240C-0250C, 0252C, 0253C, 0255C, 0257C-0259C, 0262C, 0264C, 0265C, 0268C-0271C, 0273C-0275C, 0278C-0288C, 0290C-0298C, 0300C, 0303C, 0306C, 0316C, 0318C, 0319C, 0323C, 0324C. All lot numbers of the following product codes manufactured by COBE Renal Care de Mexico S.A. de C.V., Blvd Pacifico No. 10014, Parque Industrial Pacifico, Tijuana B.C., 22480, Mexico, within the last three years. All product codes begin with 014108 followed by: 0038C, 0065C, 0134C, 0135C, 0176C, 0179C, 0190C, 0191C, 0193C, 0252C, 0253C, 0274C, 0275C, 0294C-0297C, 0299C, 0300C. MANFACTURER Gambro Renal Products, Lakewood, Colorado. RECALLED BY Manufacturer, by letter March 28, 2000, instructing users to immediately remove and destroy all the listed Clinipad products from their affected kits. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide, The Bahamas, Canada, Mexico QUANTITY 91,411 kits were distributed. REASON The antiseptic products may be contaminated with bacteria. ________ PRODUCT Various Dialysis Kits containing antiseptic products recalled by Clinipad Corporation. Recall #Z-688-0. CODE Class I: HDA Corpus - Sub, Lot #21348 HDA Corpus - Hemo, Lot # 21349 UCSF Renal - Hemo, Lot # 21333 Anderson - Hemo, Lot # 21310 DCI Jackson, Lot # 21312 TEX - Hemo, Lot # 21311 TEX - Cath, Lot # 21310 Santa CLA 15, Lot # 21374 Santa CLA 16. Lot # 21375 Santa CLA 17, Lot # 21376 Western - NY, Lot # 21317 Augusta - Sub, Lot # 21342 Augusta - Hemo, Lot # 21343 MEDCTRHOU - Sub, Lot # 21352 Madera, Lot # 21338 Ochner/H, Lot # 21392 Elmhurst - IN, Lot # 21344 Elmhurst - EXT, Lot # 21345 DCI - Atlanta - C, Lot # 21320 Hattiesburg, Lot # 21319 Class II: Clinipad Iodophor PVP, Povidone Iodine pad, Code # 9153, Lot # 911636; Cliniswab Povidone-Iodine USP stick, Code # 1261, Lot #914953. MANFACTURER Lee Medical International, Inc., Harahan, Louisiana. RECALLED BY Manufacturer, by letter on April 1, 2000 instructing their accounts to dispose of the products in question. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Texas, Louisiana, Mississippi, Arkansas, New York, California, South Carolina, Tennessee, Missouri, Virginia, Illinois, Georgia. QUANTITY Approximately 27,100 kits were distributed. REASON Class I - Products may be contaminated with bacteria. Class II - Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits for which the firm was unable to identify the code and lot numbers of Clinipad products- Class I. Kits identified as containing Clinipad Code Number 9153, Lot Number 911636 and Code Number 1261, Lot Number 914953, for which the sterility could not be assured - Class II. ________ PRODUCT Broswlow/Hinkle Kits containing Antiseptic products recalled by Clinipad Corporation. Recall #Z-689-0. CODE Product Numbers: 7700BIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO 7730ALS, 7730IALS, 7730FLY, 7730RED, 7730BLU, 7730YEL, 7730PUR, 7730WHI 7730MOD. Lot Numbers: (Products manufactured prior to 1998 are expired.) Year 2000 Year 1999 Year 1998 A,B,C 001-073 001-365 U, V, W 001-365 D,E,M Example: A004 Example: 265U Example: 116M. MANFACTURER Vital Signs, Inc., Totowa, New Jersey. RECALLED BY Manufacturer, beginning March 23, by providing warning labels to dealers to send to customers. The label to be affixed onto each kit warns the end users not to use the povidone iodine swabs. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY 5,016 kits were distributed. REASON The antiseptic products may be contaminated with bacteria. ________ PRODUCT Various I.V. Starter and Hospital Administration Kits containing Antiseptic products recalled by Clinipad Corporation: Brown Co. I.V. Start Kit, Part #561098, 100 per case; Doctors/Mass I.V. Start Kit, Part #561696, 100 per case; Hardin Memorial Hospital, O.B. Kit, Part #561715, 8 per case; Marion Medical Center I.V. Start Kit, Part #561730, 100 per case; Toledo Hospital I.V. Start Kit, Part #561735, 50 per case; Fostoria Hospital I.V. Start Kit, Part #461751, 100 per case; Bryan Infant Kit, Part #561771, 20 per case; Promedica I.V. Start Kit, Part #561816, 100 per case; Pomerene I.V. Start Kit, Part #5610941, 100 per case; Wilson Memorial Newborn, Part #562834, 12 per case; Surgery Center I.V. Start Kit, Part #562836, 100 per case; Bixby Baby Kit, Part #562843, 12 per case; Fulton Co. IV Start Kit, Part #568053, 100 per case; Tolfree Hospital, Infant Kit, Part #568600, 10 per case; Adams County I.V. Start Kit, Part #562041, 100 per case; Jefferson Memorial Newborn Kit, Part #568662, 8 per case; and Jefferson Memorial O.B. Kit, Part #568665, 10 per case. Recall #Z-690-0. CODE Uncoded. All kits containing Clinipad products are subject to recall. MANFACTURER Jones-Zylon Company, West Lafayette, Ohio. RECALLED BY Manufacturer, by letters faxed or mailed on March 22, 2000, instructing consignees to remove and destroy the Clinipad Prep Pads in the kits. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Charlotte, North Carolina. DISTRIBUTION Ohio, Missouri, Illinois, Michigan. QUANTITY 1,500 kits were distributed. REASON The antiseptic products may be contaminated with bacteria.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Capillary Dispensers. (Capillary tube or capillary blood collection tube), intended to be used by medical professionals to collect blood from a patient and to dispense the blood into a test cartridge. Recall #Z-614-0. CODE Catalog Number 111400, Lot 1489. MANFACTURER Drummond Scientific, Broomall, Pennsylvania. RECALLED BY i-STAT Corporation, East Windsor, New Jersey, by letter sent beginning October 6, 1999, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,067 units were distributed. (Each unit is a container of 50 capillary dispensers). REASON The device is subject to elevated potassium results (a positive potassium bias of about 0.8mM) while testing capillary blood samples. ________ PRODUCT Vennous Catheter Kits (central, percutaneous, and single lumen) and One Arterial Kit containing PRODUCTs recalled by Clinipad Corporation. Recall #Z-704-0. CODE Arrow PRODUCT Numbers: AI-06210-K, AI-07155-K, AJ-13122-F, AJ-23122-F, AK-00370, AK-02903, AK-04018, AK-04020, AK-04020-C, AK-04120, AK-04122, AK-04210, AK-04212, AK-04220, AK-04225, AK-04300, AK-04301, AK-04301-LF, AK-04306, AK-04510, AK-04522, AK-04550, AK-04550-A, AK- 05420-P, AK-05520-P, AK-07803-AG, AK-07903-AG, AK-08800, AK-09800, AK-09800-A, AK-09802, AK-09802-A, AK-09803, AK-09804, AK-09804-AG, AK-09805, AK-09806, AK-09806-A, AK-09807, AK-09807-A, AK-09807-AG, AK-09810, AK-09810-C, AK-09810-S, AK-09813-T, AK-09817-S, AK-09880, AK-09883-S, AK-09903-AG, AK-09903-S, AK-09903-TB, AK-09907-S, AK- 09908-S, AK-11802-F, AK-12122-F, AK-12122-H, AK-12123-F, AK-12123- H, AK-12142-CF, AK-12142-F, AK-12402, AK-12702, AK-12703, AK-12703- B, AK-12802, AK-14402, AK-14502, AK-14553, AK-14703, AK-14703-A, AK- 14703-H, AK-15122-F, AK-15122-H, AK-15123-F, AK15123-H, AK-15402, AK-155533, AK-15703, AK-15703-A, AK-15703-B, AK-15703-H, AK-15703- I, AK-15703-LF, AK-15703-UAB, AK-15703-V, AK-15802, AK-16402, AK- 16553, AK-16702, AK-17702, AK-17702-LF, AK-22122, AK-22122-F, AK- 22123, AK-22123-F, AK-22402, AK-22502, AK-22702, AK-22703, AK- 22802, AK-22854, AK-24301, AK-24306, AK-24402, AK-24703, AK-24703- A, AK-24703-B, AK-24854, AK25-25122, AK-25122-F, AK-25123, AK-25123- F, AK-25402, AK-25502, AK-25553, AK-25703, AK-25703-A, AK-25703-B, AK-25703-I, AK-25703-LF, AK-25703-UAB, AK-25802, AK-25854, AK- 26553, AK-26702, AK-27702, AK-35703-A, AK-35703-B, AM-09804, AM- 12703, AU-22122-F, AU-23122-F, AU-25122-F, BH-09810-S, BH-12702, BH- 12802, BH-22802, BP-09800, BP-09800-R, BP-09800-X, BP-09805, BT- 09810, BU-15703, BU-25703, CB-04001, CH-04500, CH-09800, CH-09903- S, CK-01000, CK01410, CK-04711, CM-09800, DG-09810-AG, DG-09810-S, DH-09806, EN-00370, EU-09903-S, EU-12702, EU-12703, FS-04510, GH- 22703-A, GH-24703-A, GH-25703-A, GS-05052-MW, GS-22122-F, GU-04020, HF-04020, HH-09803, JH-04210, JH-09903-S, JH-15703-B, JK-09802, JM- 04120, JM-07903-AG, JM-24703, JM-25703-B, JM-25854, LC-12702, LH- 04000, LH-09883-S, LI-09807, LI-09807-R, LJ-09807-S, LO-05801, LV- 15703-A, ME-04018, ME-04020, MG-09903-S, MG-25703-A, MH-090800, MH- 09810-VKS, MH-22703, MK-02031-TW, MK-02041-T, MK-02051-T, MM-09803, MM-09817-S, MM-09883, MM-24703, MM-24854, MW-09880, MS-02031-TW, MS- 020401-T, MS-02051-T, MZ-09883-S, NA-32703, NE-09805, NH-09803-B, NH-12703, NL-09903-S, NF-09880, NR-07803-AG, NR-07903-AG, NR-09810- S, NR-09903-S, NR-12703, NR-22703, NR-22802-B, NR-25854, NS-09803, OS-04510, PB-04000, PB-04001, PC-09903-S, PC-14703-AC, PG-09810-S, PH-09805, PH-09806, PK-01351, PK-01351-TW, PK-01351-W, PK-01451, PK- 01451-S, PK-01451-T, PK-01451-TW, PK-01451-W, PK-01451-WS, PK- 01452, PK-01452-W, PK-01552, PK-01552-S, PK-01552-W, PK-01552-WS, PM-09903-K, PR-05041, PR-05041-LW, PR-05041-T, PR-05052, PR-05052- LW, PR-05052-MW, PR-07051-T, PR-07051-TLW, PR-07051-TMW, PS-01651, PS-01652, PS-01671, PS-09810-S, RH-09801, RH-22703, RH-25703, RP- 09883-S, RP-09903-S, RR-22854, RV-15703, SB-09810-S, SB-09903-S, SE- 09810-SSH-04306, SH-24306, SH-25703-A, SJ-07802, SJ-09200, SJ- 09805, SJ-12702, SK-04812, SL-04710, SL-09807, SL-22802, SM-01410, SM-05503, SM-09802, SM-14703, SM-15703, SR-09907, SU-04300, SU- 09903-S, SV-09804, SV-12703, TA-09880, UA-09800, UC-09880-S, UP- 04710, UP-09806, UP-15703, UT-09880, VA-05502, VA-09802, VA-25703- B, WB-09810-S, WB-12702, WC-09804, WH-09807, WH-09883-S, WH-14703, WJ-01000, YN-09903-S, YN-15703 & YN-15703-S. MANFACTURER Arrow Intl., Inc., Reading, Pennsylvania. RECALLED BY Manufacturer, by letter on March 23, 2000, and by internet. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Charlotte, North Carolina. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Kits contain Clinipad products (alcohol prep pads, bezoin tinet swabssticks, povidone iodine prep pad, povidone iodine ointment, and alcohol swabsticks) labeled as sterile for which Clinipad is unable to assure their sterility ________ PRODUCT Power Wheelchairs: a) Power Tiger; b) P7E with duel battery box upgrade only, c) 9M; d)Excel; e) PMC; d) Ranger II. Recall #Z-705/710-0. CODE Serial Numbers 93D through 99C. MANFACTURER Invacare Corporation, Elyria, Ohio. RECALLED BY Manufacturer, by letter on April 14, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 77,408 units were distributed. REASON Wheelchairs may catch fire due to improper wiring harnes configuration. ________ PRODUCT Blood Collection Needle with Sheath, 21 GA. x 1" Needle, single use only, Sterile: Unless package is opened or damaged. Recall #Z-711-0. CODE REORDER No. N-621. All lots of product packed in green plastic pouches. MANFACTURER North American Medical Products, Inc., Albany, New York. RECALLED BY Manufacturer, by letter dated April 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION New York, California, New Jersey, Massachusetts, Canada. QUANTITY 19,200 units were distributed. REASON Package integrity - lack of assurance of sterility. ________ PRODUCT Various procedure trays containing including the following: Central Line Dressing, Midline/PICC Line Support, Subclavian On/Off, Dressing Change, Nerve Block, VAD Access, General Purpose Instrument, I.V. Start, Suture Removal, Ventriculostomy, Wound Care, Urethral/Foley Catheter, Catheter Care, under the Medcare and 14 private labels: Medical Marketing, Catalog #DK7-7178; Capital Medical Inc., Catalog #CMI-2001; UHS?HCI St. Louis, Catalog #DF8-8047; Owens and Minor (Touro Infirmary-label), Catalog #DP2-2161; Rockwell Medical, Catalog #RW-1020, 2011, 2100; Modern HomeCare, Catalog #DK7-0312; Patients Choice (Hospice or SpectraCare label), Catalog # DK7-7119 & IF9-9099; American Homepatient, Catalog #DK7-0444; OptionCare (Corporate), Catalog #DN7-7099; Children's Hospital Medical Center, Catalog #DP2-2052; Medtronic PS Medical, Catalog #46155. Recall #Z-712-0. CODE The recalled trays include approximately 68 different catalog numbers and approximately 120 different lot numbers. (NOTE: If necessary a complete of catalog numbers and lot numbers can be obtained from the New England District Office Recall Coordinator). MANFACTURER Medcare Medical Group, Inc., East Swanzey, New Hampshire. RECALLED BY Manufacturer, by telephone and letter on April 10, 2000. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide. QUANTITY 7,504 cases, containing a total of 244,022 units. REASON Procedure kits contain recalled Clinipad antiseptic products.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
________ PRODUCTS Coverall Barrier Teat Dip – dodecylbenzenesulfonic acid 500 ppm, in 1-gallon and 15-gallon containers, used as a barrier teat tip to aid in the control of mastitis. Recall #V-094-0. CODE Lot #31-939, Product Code S23. MANFACTURER Safeway Industries, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on or about September 9, 1998. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 4 1-gallon; b) 3 15-gallon containers were distributed; firm estimates none remains on the market. REASON Bacterial growth was found in a finished product sample. Product had been released prior to testing being completed. ________ PRODUCT Vedco brand NFZ Puffer, contains 0.2% nitrofurazone, packed in 1.59-ounce bottles, 12 bottles per cases, OTC veterinary medication used for the treatment of surface wounds, cuts and abrasions in these animals. Recall #V-098-0. CODE Lot #09611 EXP 2/05. MANFACTURER Hess & Clark, Inc., Ashland, Ohio. RECALLED BY Manufacturer, by telephone and letter on April 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Missouri. QUANTITY 150 cases were distributed. REASON An extended expiration date was used on the label. During filling lot # 07517 and lot #09611 were mixed. Lot # 07517 had expiration date of 11/02. Lot #09611 had an expiration date of 2/05. The mixed lot should have been assigned the expiration date of lot #07517 for 11/02 not 2/05. ________ PRODUCT Hess & Clark brand 20% Sulfaquinoxaline Sodium Solution, in 16-ounce bottles, product is added to drinking water to teat infections in chickens, turkeys, cattle and calves. Recall #V-099-0. CODE Lot #07397 EXP OCT 02. MANFACTURER Hess & Clark Inc., Ashland, Ohio. RECALLED BY Manufacturer, by letter dated February 17, 2000, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Oklahoma, Missouri, Hawaii, Pennsylvania, Iowa, Kansas, Ohio, and Texas. QUANTITY 27 cases (12 bottles per case) were distributed. REASON An extended expiration date was used on the label. Stability data existed only for 2 years as packaged in 16-ounce bottles.MEDICAL DEVICE SAFETY ALERT
===================================== ________ PRODUCT Castle Series 200 Steam Sterilizer (Powerclave), intended for sterilizing medical devices for use in hospitals and health care facilities: a)Castle Model 222: Gravity Steam Sterilizer, Double Door; b) Castle Model 233: Vacuum Steam Sterilizer, Single Door. Safety Alert #N-015/016-0. CODE Serial #s range from 97A58318 thru 99M60565. The first 3 characters represent the year and month. (A=January, etc.) The last five numbers are consistent with pressure vessel identification. NOTE: There are sterilizers within this serial number range that are NOT affected by this field correction. However, those sterilizers have different model numbers than those subject to this safety alert. MANFACTURER Getinge/Castle, Inc., Rochester, New York. ALERTED BY Manufacturer, by letter on April 12, 2000. DISTRIBUTION Nationwide and international. QUANTITY 286 sterilizers were distributed. REASON Sterilizer door opened during sterilization cycle due to damaged door hook. END OF ENFORCEMENT REPORT FOR MAY 31, 2000.####
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