July 24, 2002 02-29
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT LOTTE Margaret brand Soft Cookies. Seoul Shik Poom stick-on label declared the product as "SOFT PIE", NET WEIGHT 8.04 OZ. (228 g). CHORIPDONG(R). PRODUCT OF KOREA. Recall # F-611- 2. CODE Bar Code #801062 143795. All codes on the market at the time of the recall initiation including "2002.03.21C.J" (on side panel). RECALLING FIRM/MANUFACTURER Recalling Firm: Seoul Shik Poom, Inc., Flushing, NY, by telephone on December 1, 2001 and by letter and press release on December 5, 2001. Manufacturer: Lotte Confectionery Co., Ltd., Seoul, South Korea, Firm initiated recall is complete. REASON The product contained undeclared peanuts. VOLUME OF PRODUCT IN COMMERCE 50 cases. DISTRIBUTION NY, NJ, MA, CT, NH, MI, VA and SC. _______________________ PRODUCT Coconut Jelly candies with Konjac/Konnyaku. The product is packaged in individual serving sized plastic cups with foil lids identified as "Coconut Jelly", with the product meant to be squeezed out of the cup directly into the mouth. The 16.7 - 17 gram individual serving cups are packaged 6 per plastic bag with a paper fold-over label at the top of the bag which reads in part: "Mi Costenita *** Gelatinas Coconut Jelly *** Net Wt. 1 oz. (28g)*** Product of Mexico *** Gelatina Kannyaku *** Packed & Dist. by Yoli, Inc., Chicago, Illinois ***. UPC #14444-00451. Recall 649-2. CODE All product on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Yoli, Inc., dba Mi Costenita, Chicago, IL, by salesmen visits beginning March 19, 2002. Manufacturer: Sheng Hsiang Jen Foods, Co. Ltd., Taichung Hsien, TW. Firm initiated recall is complete. REASON This candy is in violation of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard. VOLUME OF PRODUCT IN COMMERCE At least 3,115 x 6 piece bags. DISTRIBUTION Nationwide. _______________________ PRODUCT Arnie's Bakery Classics Date Nut Cookies, 8 units per package, sold at room temperature. Recall # F-650-2. CODE All product on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Arnie's Bakery, Grand Rapids, MI, by telephone on December 14, 2001. Manufacturer: Awrey's Bakeries Inc., Livonia, MI. Firm initiated recall is complete. REASON The product contained undeclared nonfat milk. VOLUME OF PRODUCT IN COMMERCE Approx 175 packages. DISTRIBUTION MI. _______________________ PRODUCT Nature's Way Nettle capsules, 100 count bottles. Recall # F-651-2. CODE Product Code 15150; Lots Numbers are 131237, 131238, 140738, and 215229. RECALLING FIRM/MANUFACTURER Nature's Way Springville, UT, by letter on June 20, 2002. Firm initiated recall is ongoing. REASON Nettle capsules contain elevated amounts of lead. VOLUME OF PRODUCT IN COMMERCE 40,409 /100 count bottles. DISTRIBUTION Nationwide and Canada, Jamaica, New Zealand, Panama, and Saudi Arabia. ____________________ PRODUCT SWEET CANDY, NET WT. 5 oz. 141 g. PRODUCT OF CHINA. Product is mainly labeled in Chinese. According to the translation provided to NYSDAM, the product is Ho Mei Do brand Sweetened Fruit Candy (Dried Mango). Firm on label - Agent: Hing Woo Foodstuffs Inc., Hong Kong. Product OF R.O.C. Recall # F-653-2. CODE Bar Code #: 920376 820199 and no other coding. RECALLING FIRM/MANUFACTURER Recalling Firm: Sincere Trading Co. Inc., Brooklyn, NY, by letter on September 25, 2001. Manufacturer: Xinhui Cereals, Oils, Import & Export Co. of Guangdong Xinhui, Guangdong, China. State initiated recall is complete. REASON The product contained undeclared sulfites and tartrazine (certifiable as FD&C Yellow #5). VOLUME OF PRODUCT IN COMMERCE 10 cases (50 - 5 oz. packages per case). DISTRIBUTION NY, FL, VA, GA, WI, TN, MA and CT. _______________________ PRODUCT a) Chifles brand Spicy Carribean Plantain chips, 2oz., 5 oz., and 8 oz. Recall # F-654-2; b) Chifles Spicy Caribbean Cassava chips, 4 oz. Recall # F-655-2. CODE All codes are involved up to the last shipped product which has an expiration code of "9-11-2002". RECALLING FIRM/MANUFACTURER Plantain Products Co., Tampa, FL, by telephone, fax and letter on 6/12/02, and by press release on June 13, 2002 and June 14, 2002. FDA initiated recall ongoing. REASON The products contained undeclared whey. VOLUME OF PRODUCT IN COMMERCE 288 cases of 12 each DISTRIBUTION FL, TX, MD, MA and VA. _______________________ PRODUCT Tuna Salad Sandwiches, 4 oz. The Tuna Salad Sandwiches are labeled in part, "TUNA SALAD SANDWICH *** Ingredients: (tuna salad & enriched bread) *** KEEP REFRIGERATED *** Net Wt. 4oz (113g)*** ". Recall # F-656-2; Tuna Salad Croissants, 5.5 oz are individually wrapped and Ready-To-Eat Sandwiches. The firm listed on the label is: VIP Foodservice, Louisville, KY. The Tuna Salad Croissants are labeled in part, "TUNA SALAD CROSSIANT *** Ingredients: (tuna salad & butter crossiant) *** KEEP REFRIGERATED *** Net Wt. 5.5oz (155g) *** ". Recall # F-657-2. CODE No Codes. No Expiration Dates. RECALLING FIRM/MANUFACTURER International Vending, Inc., Louisville, KY, by telephone on February 27, 2002. FDA initiated recall is complete. REASON Sandwiches containing White Albacore Tuna Salad did not declare the presence of egg yolks and FD&C Yellow #5. VOLUME OF PRODUCT IN COMMERCE Approximately 97 sandwiches/croissants DISTRIBUTION KY. _______________________ PRODUCT "Nany" Coconut candy bar. Ingredients: Sugar-Glucose-Coconut- Pectin-Meksrat-Zebeb. In Egyptian, Meksrat translates to nuts and Zebeb is raisins. Recall # F-658-2. CODE All lots. Some had C-112 and others had no codes. RECALLING FIRM/MANUFACTURER Recalling Firm: Middle East Treasures Imports, South Amboy, NJ, by press release on February 8, 2002 and by telephone on March 12, 2002. Manufacturer: El-Shanawany Sons Bakery, Tanta, Egypt. State initiated recall is complete. REASON The product contains undeclared peanuts. VOLUME OF PRODUCT IN COMMERCE 21 cases. DISTRIBUTION NY, NJ and FL.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT William's Chocolate Covered Orange Peel - 5 Lb Box. Recall # F-640-2. CODE No codes on unit packaging. RECALLING FIRM/MANUFACTURER William's Candy Company Inc., Somerville, MA, by telephone and letter on April 1, 2002. Firm initiated recall is ongoing. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 4/5 lb boxes. DISTRIBUTION NY, MA and NH.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Oxygen, USP, compressed, E, M, & D-size cylinders, Rx only. The responsible firm on the label is Medirate Professional Pharmacy, Inc. dba Medicate Home Care Equipment, Farmington, MO. Recall #D-338-2. CODE Cylinders coded 050102** through 061702** (** = batch number assigned consecutively for each lot of cylinders filled that day). RECALLING FIRM/MANUFACTURER Medicate Home Care Equipment, Farmington, MO, by telephone on June 19, 2002. Firm Initiated recall complete. REASON Good Manufacturing Practice deviations (GMP) and reports of an ammonia odor. VOLUME OF PRODUCT IN COMMERCE 1,320 cylinders. DISTRIBUTION Missouri.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Desyrel Tablets (trazodone HCL tablets, USP), 100 mg, Rx only, packaged in bottles of 100 tablets(NDC 0087-0776-41) and 1,000 tablets (NDC 0087-0776-43). Recall # D-343-2. CODE 2 Lots MLS08 and MKC09. RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Co., Evansville, IN, by letters on June 11, 2002. Firm Initiated recall ongoing. REASON Lack of content uniformity-subpotent at 18 month stability. VOLUME OF PRODUCT IN COMMERCE 2 Lots MLS08 and MKC09. DISTRIBUTION Nationwide. _______________________ PRODUCT Colrex Compound Capsules, 100 capsule bottles, Rx Only, (Codeine Phosphate 16 mg, Acetaminophen 325 mg, Phenylephrine Hydrochloride 10 mg, Chlorpheniramine Maleate 2 mg). NDC # 55499-0840-1. Recall # D-351-2. CODE Lot H000449A. RECALLING FIRM/MANUFACTURER Mikart, Inc. Atlanta, GA, by phone and fax on 5/2/02. Firm initiated recall complete. REASON Low weight capsules. VOLUME OF PRODUCT IN COMMERCE 1853 bottles. DISTRIBUTION NJ. _______________________ PRODUCT Esgic-Plus Capsules (Butalbital, Acetaminophen and Caffeine Capsules, USP) 50 mg/500 mg/40 mg, 100 and 500 count bottles, Rx only, NDC# 0456-0679-01 and 0456-0679-02. Recall # D-352-2. CODE Lots D010201A, D010202A, D010203B, J010602A, J010603B and L010742A RECALLING FIRM/MANUFACTURER Mikart, Inc. Atlanta, GA, by phone and fax on April 30, 2002. Firm Initiated recall ongoing. REASON Low weight dosage units. VOLUME OF PRODUCT IN COMMERCE 23,081/100 ct. bottles; 966/500 ct. bottles. DISTRIBUTION MO.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Human Cornea Tissue, Recall # B-1325-2. CODE Tissue 02-0326-200. RECALLING FIRM/MANUFACTURER Lions Eye Bank of Texas, Houston, TX, by telephone and letter on May 1, 2002. Firm initiated recall is complete. REASON Human cornea, collected from a donor who subsequently tested positive for antibody to the Hepatitis B core antigen (anti-HBc), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 tissue. DISTRIBUTION TX. _______________________ PRODUCT Source Plasma, Recall # B-1599-2. CODE Units G16531072 and G16654072. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, City of Industry, CA, by facsimile dated October 2, 2000. Firm initiated recall is complete. REASON Blood product, which tested negative for the hepatitis B surface antigen (HBsAg) but was collected from a donor who subsequently tested repeatedly reactive for HBsAg, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Sweden. _______________________ PRODUCT a) Red Blood Cells Leukocytes Removed, Recall # B-1600-2; b) Platelets Leukocytes Removed, Recall # B-1601-2; CODE a) and b) Units 42FY29025 and 42FJ98704; RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letters and fax dated March 1 and April 1, 2002. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who had taken the prescription drug Tamoxifen, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION OH and CA. _______________________ PRODUCT Red Blood Cells, Recall # B-1603-2. CODE Unit 1889855. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter dated April 25, 2002. Firm initiated recall is complete. REASON Blood product, which was collected from a therapeutic donor but was labeled for allogeneic use, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT a) Red Blood Cells Leukocytes Removed, Recall # B-1605-2; b) Recovered Plasma, Recall # B-1606-2. CODE a) and b) Unit FS05754. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on November 17, 2001 and by letters dated November 19, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who was taking the prescription medication Lupron, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Wisconsin and Switzerland. _______________________ PRODUCT Recovered Plasma, Recall # B-1610-2. CODE Units 1135006, 1135007, 1135010, 1135011, 1135016, 1135018, 1135019, 1135024, 1135027, 1135028, 1135030, 1135035, 1135038, 1135039, 1135041, 1135044, 1135048, 1135050, 1135066, 1135106, 1135119, 1135122, 1135128, 1135131, 1135145, 1135149, 1135282, 1135286, 1135287, 1135291, 1135296, 1135301, 1135309, 1135330, 1135612, 1135614, 1135617, 1135631, 1135636, 1135637, 1135752, 1135776, 1135783, 1135786, 1135794, 1135796, 1135918, 1135919, 1135923, 1135924, 1135925, 1135926, 1135928, 1135930, 1135934, 1135935, 1135940, 1135941, 1135954, 1135968, 1135969, 1135992, 1136106, 1136109, 1136110, 1136141, 1136443, 1980001, 1980006, 1980022, 1980024, 1980028, 1980079, 1980085, 1980153, 1980178, 1980529, 1980535, 1980536, 1980555, 1980601, 1980607, 1980614, 1980622, 1980631, 1980692, 1980706, 1981027, 1981029, 1981037, 1981041, 1981046, 1981047, 1981050, 1981055, 1981063, 1981070, 1981120, 1981122, 1981150, 1981152, 1981155, 1981156, 1981157, 1981171, 1981172, 1981186, 1981198, 1981203, 1981214, 1981243, 1981244, 1981257, 1981365, 1981398, 1981403, 1981407, 1981415, 1981419, 1982296, 1982463, 1982475, 1982477, 1982478, 1982492, 1983056, 1983062, 1983066, 1983237, 1983238, 1983254, 1983264, 1983275, 1983491, 1983497, 2110199, 2110217, 2110219, 2110242, 2110244, 2110280, 2110285, 2110286, 2110287, 2110289, 2110291, 2110293, 2110295, 2110296, 2110303, 2110304, 2110306, 2110307, 2110308, 2110310, 2110311, 2110313, 2110314, 2110316, 2110320, 2110325, 2110326, 2110328, 2110329, 2110331, 2110332, 2110335, 2110338, 2110340, 2110342, 2110343, 2110351, 2110355, 2110360, 4536072, 4536076, 4536088, 4536096, 4536267, 4536271, 4536295, 4536303, 4536312, 4536319, 4536322, 4536323, 4536327, 4536343, 4536349, 4536517, 4536525, 4536526, 4536527, 4536534, 4536546, 4536570, 4536657, 4536660, 4536673, 4536814, 4536815, 4536817, 4536822, 4536838, 4536840, 4536879, 4536931, 4536954, 4536961, 4536964, 4536967, 4536973, 4536980, 4537265, 4537271, 4537272, 4537283, 4537349, 4537357, 4537361, 4537385, 4537387, 4537402, 4537425, 4537566, 4537603, 4537605, 4537606, 4537607, 4537615, 4537616, 4537618, 4537621, 4537624, 4537639, 4537644, 4537650, 4537877, 4537925, 4537945, 4537957, 4537983, 4537985, 4538502, 4538589, 4538594, 4538662, 4538801, 4538806, 4538815, 4538822, 4538823, 4538829, 4538894, 4538897, 4538938, 4538941, 4538943, 4538944, 4538966, 4538969, 4538970, 4538971, 4538978, 4538979, 4538982, 4538983, 4538985, 4538989, 4538998, 4539000, 6983466, 6983497, 7919570, 7919590, 7919602, 7919610, 7919625, 7919630, 7919712, 7919728, 7919729, 7919736, 7921087, 7921099, 7921102, 7921103, 7921104, 7921106, 7921107, 7921108, 7921109, 7921110, 7921111, 7921112, 7921113, 7921114, 7921115, 7921116, 7921118, 7921120, 7921121, 7921122, 7921123, 7921124, 7921125, 7921126, 7921128, 7921129, 7921130, 7921132, 7921142, 7921154, 7921161, 7921164, 7921184, 7921217, 7921268, 7921319, 7921331, 7921340, 7921342, 7921369, 7921396, 7921399, 7921400, 7921401, 7921409, 7921410, 7921412, 7921464, 7921480, 7921484, 7921492, 7922083, 7922092, 7922245, 7922251, 7922257, 7922258, 7922262, 7922272, 7922286, 7922322, 7922323, 7922329, 7922330, 7922331, 7922336, 7922344, 7922345, 7922346, 7922348, 7922351, 7922353, 7922354, 7922355, 7922357, 7922360, 7922461, 7922482, 7922493, 7923503, 7923513, 7923521, 7923523, 7923524, 7923526, 7923531, 7923536, 7923539, 7923542, 7923546, 7923547, 7923549, 7923550, 7923552, 7923553, 7923554, 7923555, 7923556, 7923558, 7923563, 7923565, 7923567, 7923568, 7923574, 7923583, 7923686, 7923706, 7923708, 7923726, 7923765, 7923777, 7923816, 7923820, 7923929, 8756008, 8756023, 8756087, 8756109, 8756112, 8756117, 8756670, 8756672, 8756689, 8756833, 8756836, 8756839, 8756921, 8757500, 8757501, 8757514, 8757554, 8757575, 8757580, 8757592, 8757613, 8757619, 8757752, 8757767, 8758214, 8758269, 8758293, 8758302, 8758330, and 8758374. RECALLING FIRM/MANUFACTURER Nassau Health Care Corporation, Nassau University Medical Center, East Meadow, NY, by letter dated May 22, 2002. REASON Blood products, which lacked assurance of being tested adequately for infectious diseases, were distributed. VOLUME OF PRODUCT IN COMMERCE 427 Units. DISTRIBUTION NJ. _______________________ PRODUCT Source Plasma, Recall # B-1611-2. CODE Unit 71554013, 71700496, 71698632, 71695655, 23525047, 23526297, 23527713, 23500089, and 23892057. RECALLING FIRM/MANUFACTURER BioLife Plasma Services Limited Partnership, Sera-Tec Biologicals L.P., Richmond, KY, by letter dated January 23, 2002. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who was previously deferred for high risk behavior, was distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells Leukocytes Removed, Recall # B-1614-2; b) Cryoprecipitated AHF, Recall # B-1615-2; c) Recovered Plasma, Recall # B-1616-2. CODE a); b) and c) Unit 1762716. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax dated November 11 and November 28, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who was taking Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX and FL. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1631-2. CODE Unit number 4215769C. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated November 26, 2001. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AK. _______________________ PRODUCT Platelets Pheresis Leukocytes Removed, Recall # B-1632-2. CODE 7045473 unit. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax dated July 17, 2001. Firm initiated recall is complete. REASON Blood product, which may not have met product specifications due to the platelet count not having been performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1661-2. CODE Unit number 50C33301. RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region, Toledo, OH, by telephone on April 17, 2002 and by letter dated April 26, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor whose hemoglobin level was documented as unacceptable, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1667-2; b) Platelets, Leukocytes Reduced, Recall # B-1668-2. CODE a) and b) Unit number 42FH09784. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter dated April 15, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Recall # B-1669-2. CODE Unit number 23143-7483. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on January 30, 2002 and by telephone on April 2, 2002. Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MT. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1670-2. CODE Unit number 13FY73059. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated May 15, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells, Recall # B-1673-2. CODE Unit 33LL02634. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region,Farmington, CT, by letter dated April 16, 2002. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who engaged in high risk behavior, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CT and CA. _______________________ PRODUCT Anti-thymocyte Globulin (Rabbit), Thymoglobulin?, in 25 mg vial, freeze- dried powder, Recall # B-1675-2. CODE Lots TH007-5 and TH007-6. RECALLING FIRM/MANUFACTURER Recalling Firm: SangStat Medical Corporation, Freemont, CA, by telephone and letter on or about August 9, 2000. Manufacturing Firm: IMTIX SangStat, Marcy l’Etoile, France. Firm initiated recall is complete. REASON PRODUCT, which exceeded the acceptable U.S. limit for Lymphocytotoxic activity, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 lots. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1676-2; b) Recovered Plasma, Recall # B-1677-2. CODE a) Unit numbers 2160086, 2160427, 2160629, 2160799, and 2161079; b) Unit number 2160255. RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH, by letter dated June 3, 2002. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to a history of medication with the drug Evista, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION OH and FL. _______________________ PRODUCT Platelets, Leukocytes Reduced, Recall # B-1678-2. CODE Unit number 24GL29661. RECALLING FIRM/MANUFACTURER The American National Red Cross, River Valley Region,Louisville, KY, by telephone on April 27, 2002. Firm initiated recall is complete. REASON Blood product, associated with a unit of Red Blood Cells that was found to contain clots, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1679-2; b) Platelets, Recall # B-1680-2; c) Fresh Frozen Plasma, Recall # B-1681-2; d) Recovered Plasma, Recall # B-1682-2. CODE a)and b) Unit numbers 22KX27955, 22KC05672, and 22LV46935; c) Unit number 22KX27955; d) Unit numbers 22KC05672 and 22LV46935. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on July 6, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION NJ, PA and CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1683-2; b) Platelets, Recall # B-1684-2; c) Fresh Frozen Plasma, Recall # B-1685-2. CODE a); b) and c) Unit number 22KY29965. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on July 5, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NJ and PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1686-2; b) Platelets, Recall # B-1687-2; c) Fresh Frozen Plasma, Recall # B-1688-2. CODE a); b) and c) Unit number 22GY91355. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on February 16, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION AL, NJ and PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1693-2; b) Recovered Plasma, Recall # B-1694-2. CODE a) and b) Unit numbers 22FF50824 and 22LT11445; RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on August 13, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis B surface antigen (HBsAg), but were collected from an ineligible donor due to previous positive testing for HBsAg, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION PA, CA and Switzerland. _______________________ PRODUCT a) Platelets, Pheresis, Recall # B-1698-2; b) Platelets, Phereis, Leukoreduced, Recall # B-1699-2; c) Platelets, Pheresis, Irradiated, Recall # B-1700-2; CODE a) Units 29FP72614 - split unit; b) and c) Unit 29FP72208. RECALLING FIRM/MANUFACTURER American Red Cross, Mid-Atlantic Regional Blood Services, Norfolk, VA, by telephone on May 4, 2001 and by letter dated May 15, 2001. Firm initiated recall is complete. REASON Platelets, not tested according to the manufacturer’s instructions for ABO/Rh and Syphilis using the Olympus PK7200, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1711-2. CODE Unit number 12FN76527. RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated April 26, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1712-2. CODE Unit number 12FN76500. RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated April 26, 2002. Firm initiated recall is complete. REASON Blood product collected from an unsuitable donor based on travel to an area considered endemic for malaria was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1713-2. CODE Unit numbers 09GN94781, 09FX06136, and 09GN94470. RECALLING FIRM/MANUFACTURER The American National Red Cross, Midwest Region, Omaha, NE, by letters dated April 5 and August 3, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NE. _______________________ PRODUCT Platelets Pheresis, Recall # B-1715-2. CODE Unit number LQ07982. RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, by telephone on February 7, 2002. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Source Plasma, Recall # B-1717-2. CODE Unit numbers 9FV820, 9FU613, and 9EJ160. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Kansas City, MO, by letter on October 29, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1718-2. CODE Unit numbers CCDYTM and CCDYHD. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Kansas City, MO, by letter on October 15, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1719-2. CODE Unit numbers CCFHXG, CCFHND, CCFHFX, 9K0778, 9FX242, 800610, 80Z665, 80Z401, 80Z226, 80Z041, and 80Y941. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Kansas City, MO, by letter on November 28 and 29, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION IL and Switzerland. _______________________ PRODUCT Red Blood Cells, Recall # B-1721-2. CODE Unit numbers G43650RB1 and G43650RB2. RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, IL, by letter on May 15, 2002. Firm initiated recall is complete. REASON Blood products, that were below the firm’s specification for red blood cell volume, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1722-2; b) Platelets, Recall # B-1723-2; c) Fresh Frozen Plasma, Recall # B-1724-2; d) Recovered Frozen Plasma, Recall # B-1725-2. CODE a) Unit numbers 4071043 and 7546703; b) and c) Unit number 7546703; d) Unit number 4071043. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on February 20 and 21, 2002 and by letter on February 22, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION IL and Scotland.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Source Plasma, Recall # B-1320-2. CODE Unit (1 unit) TPG005481. RECALLING FIRM/MANUFACTURER American Plasma, Inc., Casa Grande, AZ, by fax dated October 9, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor that did not answer the medical history questions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Recovered Plasma, Recall # B-1602. CODE Units 42FY29025 and 42FJ98704. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letters and fax dated March 1 and April 1, 2002. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who had taken the prescription drug Tamoxifen, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH and CA. _______________________ PRODUCT Source Plasma, Recall # B-1604-2. CODE Units 33BPCHKJ, 33BPCHNB, 33BPCHRJ, 33BPCHVS, 33BPCJGD, 33BPFCVF, and 33BPFCXX RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., West Allis, WI, by letter dated November 1, 2001. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who had with a medical history of seizures, was distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1612-2. CODE Unit 61697287. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Tacoma, WA, by letter dated January 21, 2002. Firm initiated recall is complete. REASON Blood product, which was collected in a manner that compromised the sterility of the collection system, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1613-2. CODE Unit 55480147. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Tacoma, WA, by letter dated January 18, 2002. Firm initiated recall is complete. REASON Blood product, which was collected in a manner that compromised the sterility of the collection system, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1662-2. b) Recovered Plasma, Recall # B-1663-2. CODE a) Unit numbers 7155548 and 7155587; b) Unit numbers 7155513, 7155545, and 7155552. RECALLING FIRM/MANUFACTURER Department of the Air Force, 74th Medical Group/SGSC, Wright Patterson AFB, OH, by telephone on October 9, 2001 and by letters on January 30 and 31, 2002. Firm initiated recall is complete. REASON Blood products, collected in expired collection bags, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION PA, Germany and Italy. _______________________ PRODUCT Red Blood Cells, Recall # B-1664-2. CODE Unit numbers 0345118, 1607671, and 2276751. RECALLING FIRM/MANUFACTURER Inland Northwest Blood Center, Spokane, WA, by telephone on January 10, 2002. Firm initiated recall is complete. REASON Blood products exposed to unacceptable storage temperatures were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1665-2. CODE Unit numbers 21KJ69600, 21KZ09020, and 21KG69152. RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on February 22 and 24, 2002 and April 3, 2002, and by letter April 8, 2002. Firm initiated recall is complete. REASON Blood products, that did not have the additive solution included, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WA and OR. _______________________ PRODUCT Source Plasma, Recall # B-1666. CODE Unit number SBG009212. RECALLING FIRM/MANUFACTURER SeraCare, Inc. (formerly American Plasma Systems), South Bend, IN, by letter on September 17, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________ PRODUCT Red Blood Cells Leukocytes Removed, Recall # B-1671-2. CODE Unit 04GF17059. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New England Region, Dedham, MA, by letter dated March 18, 2002. Firm initiated recall is complete. REASON Blood product, which was collected from a donor in which the question “Have you ever had Chagas’ disease or babesiosis,” was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NH. _______________________ PRODUCT Cryoprecipitated AHF, Recall # B-1672-2. CODE Units 1845242, 1850915, 1848697, 1846336, 1850914, 1846236, 1850912, 1846230, and 1850923. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax dated October 3, 2001. Firm initiated recall is complete. REASON Blood products, which was stored outside of acceptable storage temperatures, was distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION TX. _______________________ PRODUCT Recovered Plasma, Recall # B-1674-2. CODE Unit 33LK22782. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region,Farmington, CT, by letter dated April 16, 2002. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who engaged in high risk behavior, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CT and CA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1695-2. CODE Unit number 15392-1714. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 9, 2002. Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete. REASON Blood products, that may have been shipped at an incorrect temperature, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MT. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1714-2. CODE Unit numbers 09FJ87049 and 09FJ87056. RECALLING FIRM/MANUFACTURER The American National Red Cross, Midwest Region, Omaha, NE, by telephone on December 5, 2000 and by letter dated December 20, 2000. Firm initiated recall is complete. REASON Blood products that were possibly out of controlled storage for more than 30 minutes were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NE. _______________________ PRODUCT Red Blood Cells, Recall # B-1716-2. CODE Unit numbers LV23950, LV23960, and LV23952. RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, by telephone on February 22, 2002. Firm initiated recall is complete. REASON Blood products, that did not have the additive solution included, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION PA. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-1720-2. CODE Unit numbers 3991231, 3991232, 3991233, and 3992264. RECALLING FIRM/MANUFACTURER Department of the Army, Armed Services Blood Bank Center, Madigan Army Medical Center, Tacoma, WA, by letter on May 24, 2001. Firm initiated recall is complete. REASON Blood products, prepared more than eight hours after collection of the corresponding unit of Whole Blood, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA, NM and VA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT a) EasyVision CT/MR Release 2 Model Numbers: 9896-010-1336x and 9896-010-1338x where x= 1,2, or 3. Recall # Z-1143-2. b) EasyVision Release 4 Model Number: 9896-050-0961; 9896-050-00921, 9896-050-03651. Recall # Z-1144-2. CODE All units of the model numbers listed. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Shelton, CT, by letter dated June 20, 2001. Manufacturer: Philips Medical System, Nederlands, BV Best. Firm initiated recall is ongoing. REASON Transferred Image Data may result in the reversal of Left/Right Indicators. VOLUME OF PRODUCT IN COMMERCE 65 units Easy Vison Rel 2; 118 units EasyVision Rel 4. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I
_______________________ PRODUCT Product is labeled in part: "Equine Miracle Corp. Rt 2, Box 162 Normangee, TX 77871***"The Original" MIRACLE PAINT contents: 4 Fl. Oz*** Main Ingredients: Mercuric Chloride, Isopropal Alcohol, in a Herbal Base". Recall # V-146-2. CODE: All codes remaining on the market are recalled. RECALLING FIRM/MANUFACTURER Equine Miracle Corp. Grapeland, TX, by press release, telephone and letters on May 30, 2002. FDA initiated recall ongoing. REASON Unapproved new animal drug contains mercuric chloride. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT Trader Joe's brand canned cat food, 6 oz. easy open cans. Cans are labeled in part "TRADER JOE'S *** NET WT. 6 OZ. *** Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA ***". Flavors include: a) Chopped Grill. Recall # V-147-2; b) Turkey & Giblets. Recall # V-148-2; c) Fish Salmon & Rice. Recall # V-149-2; d) Chicken Turkey & Rice. Recall # V-150-2; e) Beef Liver & Rice. Recall # V-151-2. CODE To be determined. RECALLING FIRM/MANUFACTURER Uni-Heartous Pet Products USA, Inc., Seattle, WA, by telephone on November 13, 2001. Firm initiated recall is complete. REASON Swollen cans - potential post process contamination. VOLUME OF PRODUCT IN COMMERCE 21,527 cases. DISTRIBUTION CA and MA. _______________________ PRODUCT ADM Penicillin 100 Type A Medicated Article containing penicillin (from procaine penicillin) 60 grams/lb., packed in 50-lb. bags, for further manufacture of feed, for increased weight gain and improving feed efficiency in swine and turkeys. Recall # V-152-2. CODE Lot 1040149D, Exp. 09-02. RECALLING FIRM/MANUFACTURER ADM Animal Health and Nutrition Division, Des Moines, IA, by telephone on May 22, 2001. Firm initiated recall is complete. REASON The product was inadvertently manufactured using Penicillin 100% rather than 50%, causing it to be superpotent. VOLUME OF PRODUCT IN COMMERCE 3,250 lbs. (65/50-lb. bags). DISTRIBUTION IA, SD, MN, OH and IL. _______________________ PRODUCT 358 – Co-op Lamb Grower/Finisher Hi-Energy – BOV, packaged in 50 pound bags. Recall # V-153-2. CODE 90772358. RECALLING FIRM/MANUFACTURER Tennessee Farmers Cooperative, Lavergne, TN, by telephone on May 7, 2002. Firm initiated recall is ongoing. REASON Excessive magnesium in product. VOLUME OF PRODUCT IN COMMERCE 121- 50 pound bags. DISTRIBUTION TN.END OF ENFORCEMENT REPORT FOR JULY 24, 2002 ####
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