March 22, 2000 00-12
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Hommus with Vegetables, in 8-ounce plastic containers. Recall #F-191-0. CODE JAN29. MANUFACTURER Wakim's Foods, Inc., Bristol, Pennsylvania. RECALLED BY Manufacturer, by press release on January 21, 2000, followed by visit. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Pennsylvania. QUANTITY 202 units. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT Tuv Taam Salads brand Sliced Smoked Nova Salmon, cold smoked and vacuum packed, net weight 8 ounces. Recall #F-192-0. CODE Sell by 112999. MANUFACTURER Banner Smoked Fish, Inc., Brooklyn, New York (contract manufacturer). RECALLED BY Tuv Taam Corporation, Brooklyn, New York, by letter on November 8, 1999, and by press release issued by the New York State Department of Agriculture and Markets (NYSDAM). Completed recall resulted from sample analysis and follow-up by NYSDAM. DISTRIBUTION New York and New Jersey, QUANTITY 450 packages were distributed. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT a) Cold Smoked and Vacuum Packed Blue Ribbon brand Smoked Sable; b) Blue Ribbon brand Smoked Whitefish Salad, in 8-ounce plastic tubs. Recall #F-193/194-0. CODE a) "1108"; b) "Sell by 1120". MANUACTURER Blue Ribbon Smoked Fish Company, Brooklyn, New York. RECALLED BY Manufacturer, by letter dated November 5, 1999, followed by E-mail and by press release. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY a) 67 pounds (25 plates); b) 100 8-ounce units were distributed. REASON Products were contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Shellstock Oysters and Shucked Oysters harvested during the period of January 4, 2000 through January 21, 2000 from the harvest area #1642 in Apalachicola Bay, Florida (Cat Point Oyster Bar). Recall #F-189/190-0. CODE All oysters with an expiration date of January 18, 2000 through February 4, 2000 (reflects Florida's 14 day expiration dating). MANUFACTURER/HARVESTER Multiple certified shellfish shippers in the state of Florida. RECALLED BY Manufacturer/harvester, by telephone, fax, and/or visit, on or about January 25, 2000. Completed recall resulted from sample analysis and follow-up by the Florida Department of Agriculture and Consumer Services. DISTRIBUTION Florida, Georgia, South Carolina, Alabama, North Carolina, Maryland. QUANTITY Approximately 454,860 pounds. REASON Products may be contaminated with Norwalk virus. ________ PRODUCT Rice Dream Non-Dairy Beverage, in 32-fluid ounce containers. Recall #F-195-0. CODE DEC/14/00/A xx:xx:xx/4 (on top of container) 4A12149 (x's represent time code) on the bottom of the containers. MANUFACTURER California Natural Products, Lathrop, California (packer). RECALLED BY Imagine Foods, Inc., Palo Alto, California (distributor), by letter on January 25, 2000, and by press release on January 27, 2000, followed by telephone and fax. Firm-initiated recall ongoing. DISTRIBUTION Arizona, Arkansas, Colorado, Florida, Illinois, Kansas, Louisiana, Mississippi, Missouri, New Mexico, Nebraska, Oklahoma, Tennessee, Texas. QUANTITY 375 cases (12 units per case) were distributed. REASON The organism Bacillus cereus may be present in the product.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Orange Juice Products in 64-ounce, 96-ounce, and 120-ounce containers: a) Minute Maid Premium Orange Juice, Original b) Minute Maid Premium Orange Juice, Country Style c) Minute Maid Premium Orange Juice, Calcium Rich d) Minute Maid Premium Orange Juice, Orange Passion e) Minute Maid Premium Orange Juice, Orange Tangerine f) Minute Maid Premium Orange Juice, Pulp Free. Recall #F-182/187-0. CODE 64 oz. package XXX XX SI YY:YYA or XXX XX SI YY:YYB 96 and 128 oz. package XXX XX SI YY:YY Where "XXX XX" is a date code between SEP 22 and OCT 21 and "YY:YY" is a time code. MANUFACTURER Superstore Industries, Turlock, California. RECALLED BY The Minute Maid Company, Houston, Texas, by visit beginning on September 23, 1999. Firm-initiated recall complete. DISTRIBUTION California, Pacific Northwest including Alaska, Utah. QUANTITY 339,805 cases were distributed; firm estimates none remains on the market. REASON Products may be contaminated with mold. ________ PRODUCT Gourmet Flavors French Vanilla, syrup used to flavor espresso drinks. Recall #F-188-0. CODE 01-18-99 through 05-30-99. MANUFACTURER Stirling Foods, Inc., Kent, Washington. RECALLED BY Manufacturer, by telephone in mid-April 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Approximately 47,000 pounds were distributed. REASON Product may be contaminated with yeast.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Voltaren(r)-XR Extended Release Tablets (Diclofenac Sodium), 100 mg, in 100 count bottles, Rx used for chronic therapy of osteoarthritis and rheumatoid arthritis, and for the treatment of ankylosing spondylitis. NDC 0028-0205-01. Recall #D-251-0. CODE Lot # 104A7322 EXP 9/01. MANUFACTURER Novartis Pharma AG, Stein, Switzerland (bulk). RECALLED BY Novartis Pharmaceuticals Corporation, Suffern, New York (repacker/labeler), by fax on December 29, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 9,750 bottles were distributed. REASON Dissolution failure (release rate) at 4 and 8 hour time period(s). ________ PRODUCT Antacid Calcium Regular Strength, 500 mg, OTC in 150 tablet bottles. Recall #D-250-0. CODE NDC 62211-024-02. Lot 9D02410 EXP 05/2001. Lot 9K02413 EXP 10/2002. MANUFACTURER A&Z Pharmaceutical, Inc., Hauppauge, New York. RECALLED BY Manufacturer, by letters on November 4-5, 1999, and December 8, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10,336 bottles of lot 9D02410 and 3,510 bottles of lot 9K02413 were distributed. REASON Mislabeling - Supplement facts labeling panel incorrectly lists calcium level per serving at 4000 mg. ________ PRODUCT Oxygen, USP, Compressed, in size H cylinders. Recall #D-252-0. CODE Lot #266-01301-01-0201. MANUFACTURER Air Products & Chemicals, Inc., Guayanilla, Puerto Rico. RECALLED BY Manufacturer, by telephone on January 26, 2000, followed by letter dated January 28, 2000. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 20 cylinders were distributed. REASON Mislabeling - Incorrect lot number. ________ PRODUCT Decadron(r) Phosphate Injection (Dexamethasone Sodium Phosphate), USP, 4 mg per 5 ml injection, Rx. NDC #0006-7268-03. Recall #D-253-0. CODE Lot Numbers: 0580H, 0874H, 1476H, 0051J, 0329J, and 1577H. MANUFACTURER Merck and Company, West Point, Pennsylvania. RECALLED BY Manufacturer, by letter dated February 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 51,691 vials were distributed. REASON Product degradation at 12-month stability - single degradate.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Corneas. Recall #B-454-0. Graft Identification Numbers: 0264-93-01, 0264-93-02, 0283-94-01, 0283- 94-02, 0056-96-01, 0056-96-02, 0104-96-01, 0104-96-02, 0677-97-01, 0677- 97-02, 0360-98-01, 0360-98-02, 0376-98-01, 0688-98-01, 0098-99-01, 0098- 99-02, 0103-99-01, 0103-99-02, 0198-99-01, 0198-99-02, 0221-99-01, 0221- 99-02, 0225-99-01, 0225-99-02, 0238-99-01, 0267-99-01, 0267-99-02, 0018- 00-01, 0018-00-02. MANUFACTURER Lions Medical Eye Bank and Research Center of Eastern Virginia, Norfolk, Virginia. RECALLED BY Manufacturer, by telephone and/or letters on February 22, 1999, A April 22, 1999, June 24, 1999, August 3, 1999, January 5 and 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Virginia, Illinois, Florida, South Carolina, Missouri, Georgia, North Carolina, South Dakota, Texas, Minnesota, Ohio, Washington state, Nebraska, California, and international. QUANTITY 29 corneas. REASON Corneas collected from donors who tested repeatedly reactive for either the antibody to the Hepatitis B core antigen (anti-HBc), HbsAg or anti- HTLV-I/II, or HIV-p-24 antigen which was not confirmable by PCR. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-508/509-0. CODE Unit #42G23612. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated November 15, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor with a history of hepatitis A and jaundice. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-510/511-0. CODE Unit #20V09975. MANUFACTURER American Red Cross, Boise, Idaho. RECALLED BY Manufacturer, by letter dated December 21, 1999. Firm-initiated recall complete. DISTRIBUTION Utah. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had traveled to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets, Pooled. Recall #B-512/514-0. CODE Unit Numbers: a) P103615; b) 1M1383; c) P103615. MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington. RECALLED BY Manufacturer, by letter dated September 8, 1999. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who lived in an area designated as endemic for malaria.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Corneas. Recall #B-455-0. CODE Graft Identification Numbers: 0571-97-01, 0571-97-02, 0019-99-01, 0019-99-02, 0071-99-01, 0071-99-02, 0286-99-01, 0286-99-02. MANUFACTURER Lions Medical Eye Bank and Research Center of Eastern Virginia, Norfolk, Virginia. RECALLED BY Manufacturer, by telephone and/or letters on February 22, 1999, April 22, 1999, June 24, 1999, August 3, 1999, January 5 and 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Virginia, Illinois, Florida, South Carolina, Missouri, Georgia, North Carolina, South Dakota, Texas, Minnesota, Ohio, Washington state, Nebraska, California, and international. QUANTITY 7 corneas. REASON Corneas collected from donors who tested repeatedly reactive for either the antibody to the Hepatitis B core antigen (anti-HBc), HbsAg or anti- HTLV-I/II, or HIV-p-24 antigen which was not confirmable by PCR. ________ PRODUCT Red Blood Cells. Recall #B-540-0. CODE Unit #KW658109. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by telephone on August 26, 1999. Firm-initiated recall complete. DISTRIBUTION New Hampshire. QUANTITY 1 unit. REASON An overweight unit of red blood cells was distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Elecsys Troponin T Immunoassay for the in-vitro quantitative determination of troponin T in human serum and plasma: a) Catalog #2017423, Elecsys Tronponin T STAT Immunoassay, 100 Tests; b) Catalog 2017644, Elecsys Tronponin T Immunoassay, 100 test. Recall #Z-426/427-0. CODE a) Lot Numbers: 19862701 EXP 12-31-2000 and 19829401 EXP 03-31-2000; b) 19864201 EXP 12-31-2000. MANUFACTURER Roche Diagnostics Corporation, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated December 13, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 13,000 units. REASON The devices may give test results lower than actual troponin T results when heparinized plasma samples are used. ________ PRODUCT Strep A Tests, an in-vitro diagnostic medical device intended for the qualitative detection of group "A" streptococcal antigen from throat swabs or confirmation of presumptive group "A" streptococcal colonies recovered from culture: a) OSOM Strep A Test (Brand for Wyntek); b) Signify Strep A Test (Brand for Abbott Labs.); c) ACCEAVA Strep A Component-Test Sticks (Brand for Biostar). Recall #Z-444/446-0. CODE a) Product No. 141, Lot Nos. 7301, 7310; and Product No. 998, Lot No. 7310-10; b) Product No. 99-0347, Lot Nos. 59947M200, 59948M200, 59949M200, 59951M200, 61473M200 through 61476M200 c) Catalog No. ACCGAS-C Lot Nos. 017294, 017297, 017301, 017306, 017313, 017315; and Catalog No. ACCGAS10-C, Lot No. 017301-10. MANUFACTURER Wyntek Diagnostics, Inc., San Diego, California. RECALLED BY Manufacturer, by telephone followed by fax on February 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION The OSOM product name was distributed Nationwide. The Signify brand was distributed solely to Abbott Laboratories, Abbott Park, Illinois. The Acceava brand was solely distributed to Biostar, Inc., Boulder, Colorado. QUANTITY OSOM (50 count) 1,565 OSOM (10 count) 33 SIGNIFY 20,435 ACCEAVA (50 count) 13,695 ACCEAVA (10 count) 250 were distributed. REASON The devices may sporadically show color trace with the negative control, producing a false positive reading on an external negative control. ________ PRODUCT Blood Collection Reservoirs, indicated for use with patients undergoing cardiopulmonary bypass or autotransfusion procedures: a) Blood Collection Reservoirs, Models EL240 and EL2120 b) Cardiotomy Reservoirs, Models EL400, EL402, and EL404. Recall #Z-447/448-0. CODE All lots. MANUFACTURER Medtronic Mexico, S. de R.L. de C.V., Tijuana, Mexico. RECALLED BY Medtronic Perfusion Systems, Minneapolis, Minnesota, by letter on March 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 380,477 units were distributed; firm estimated that 5,000 units remained on market at time of recall initiation. REASON There are holes in some of the sterile packages.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Light Diagnostics Simulfluor HS/VZV immunofluorescence Assay, intended for the simultaneous detection and identification of herpes Simplex (HSV) 1 and 2 and Varicella-Zoster Virus (VZV) form patients with vesicular, oral, or skin lesions, using direct specimens and culture confirmation. Recall #Z-443-0. CODE Catalog #3295, Lot #19102679. MANUFACTURER Chemicon International, Inc., Temecula, California. RECALLED BY Light Diagnostics, Div. Chemicon International, Inc., Temecula, California, by letter on or before February 16, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Arizona, California, Connecticut, Florida, Kansas, Maryland, United Kingdom, Canada, Switzerland. QUANTITY 12 kits were distributed. REASON Labeling error - The primary reagent, labeled in part "SimuFlour HSV/VZV ***EXP 12/00" should bear the expiration date "02/01: as indicated on the box end label.END OF ENFORCEMENT REPORT FOR MARCH 22, 2000. ####
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