FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

October 21, 1998
98-42

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT
Refrigerated cookie dough, retail packages are labeled as "Pillsbury Chocolate Chip Cookies" and cases are labeled as "Pillsbury Chocolate Chip with Walnuts Cookies." Recall #F-009-9.

CODE
Retail packages are coded with "For best results use before" dates of "NOV 18 J" and "NOV 18 K." Cases are coded "NOV 18."

MANUFACTURER
The Pillsbury Company, Denison, Texas.

RECALLED BY
The Pillsbury Company, Minneapolis, Minnesota, by electronic mail and by press release on September 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
8,824 cases (12 18-ounce packages per case) were distributed.

REASON
Product contains undeclared walnuts.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT
Natacyn Sterile Ophthalmic Suspension (Natamycin Ophthalmic Suspension, USP), 5% Anti-Fungal Ophthalmic Suspension, in 15 ml glass bottles with sterile dropper assemblies, Rx for topical ophthalmic administration. NDC #0065-0645-15. Recall #D-001-9.

CODE
Lot numbers: ADM7 EXP 11/30/98, AH36 EXP 5/31/99, AH9D EXP 8/31/99.

MANUFACTURER
Alcon Laboratories, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by letter dated September 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5,972 units were distributed; FDA estimates very little, if any product remains on the market.

REASON
Contamination - Some units may contain particles from the lining (glass) of a manufacturing vessel.

PRODUCT
Compressed Medical Oxygen, USP, in D, E, and M-6 aluminum and steel cylinders. Recall #D-002-9.

CODE
All lot codes.

MANUFACTURER
Omega Medical Equipment, Inc., doing business as Mountain Air Services, Pennington Gap, Virginia.

RECALLED BY
Manufacturer, by visit on September 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia, Kentucky, Tennessee.

QUANTITY
Firm estimated that less than 50 cylinders remained on market at time of recall initiation.

REASON
Current Good Manufacturing Practice deviations, including but not limited to failure to assay for potency.

UPDATE
Inwood Laboratories, Inc. (Inwood, New York), Recall #D-100/103-8 which appeared in the March 15, 1998, April 1 and 15, 1998, July 29, 1998, August 26, 1998, September 23, 1998 Enforcement Reports has been extended as follows: Propranolol HCl 60 mg Extended Release (ER) Capsules, 100 count bottles, Lots 7F047, 7H003, 7K017, 8A043. Propranolol HCl 80 mg ER Capsules, 100 count bottles, Lot 7F049. Propranolol HCl 120 mg ER Capsules, 100 count bottles, None. Propranolol HCl 160 mg ER capsules, 100 count bottles, Lot 7F062.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

PRODUCT
Advanced Formula Zenate Tablets, Rx prenatal multivitamin/mineral supplement tablets, film coated in 30-unit dose cartons. Recall #D-003-9.

CODE
Lot #88760 EXP 6/99.

MANUFACTURER
Leiner Health Products, Garden Grove, California.

RECALLED BY
Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter dated September 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
47,930 cartons were distributed.

REASON
Subpotency - Riboflavin and Thiamine Mononitrate.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT
Source Plasma For Use in Manufacturing Non-injectable Products. Recall #B-014-9.

CODE
Unit numbers: TR-16271, TR-16276, TR-16021, TR-16095, TR-16102, TR-16124, TR-16132, TR-16176, TR-16179, TR-13871, TR-13913, TR-14494, TR-14774, TR-15068, TR-15277, TR-15664, TR-15670.

MANUFACTURER
Trimar Hollywood, Inc., Reseda, California.

RECALLED BY
Manufacturer, by letter dated August 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
California and Texas.

QUANTITY
17 units were distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus (HIV-1/2), but were collected from a donor who on several occasions had previously tested repeatedly reactive for the antibody, Western Blot Indeterminate or negative.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-015/016-9.

CODE
Unit #C02749.

MANUFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame, California.

RECALLED BY
Manufacturer, by letter and or fax dated either May 13, 1998 or April 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had a tattoo within 12 months of donation.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets; d) Platelets, Pheresis; e) Recovered Plasma. Recall #B-019/023-9.

CODE
Unit numbers: a) 03V78812, 03G27943, 03M44233, 03FC15556, 03FC20195, 03M61766, 03FT10967, 03FC25483, 03G53472, 03FL37839 b) 03M44233, 03M61766, 03FT10967, 03FC25483 c) 03V78812, 03G27943, 03M44233, 03FC15556, 03FV01385, 03FC20195, 03M61766, 03FT10967, 03FC25483, 03G53472, 03FL37839 d) 03P67256, 03P68999, 03P75118, 03P76163, 03P76967, 03P79776 e) 03V78812, 03G27943, 03FC15556, 03FV01385, 03FC20195, 03G53472, 03FL37839.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter dated April 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia and Massachusetts.

QUANTITY
a) 10 units; b) 4 units; c) 11 units; d) 6 units; e) 7 units were distributed.

REASON
Blood products which tested negative for the antibody to the human immunodeficiency virus (HIV-1/2), but were collected from a donor who had previously tested repeatedly reactive for the antibody, Western Blot indeterminate.

PRODUCT
Red Blood Cells. Recall #B-025-9.

CODE
Unit #18214-4858.

MANUFACTURER
United Blood Services, Cheyenne, Wyoming.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Wyoming.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported living in an area designated as endemic for malaria.

PRODUCT
Red Blood Cells. Recall #B-026-8.

CODE
Unit #12428-9229.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on April 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico.

QUANTITY
1 unit was distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-027/028-9.

CODE
Unit numbers: a) 01KG29821, 01E24426; b) 01KG29821.

MANFACTURER
American Red Cross Blood Services, Rochester, New York.

RECALLED BY
Manufacturer, by letter dated December 30, 1997. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
a) 2 units; b) 1 unit.

REASON
Blood products were collected from a donor taking the drug Purinethol.

PRODUCT
Platelets, Pheresis. Recall #B-029-9.

CODE
Unit #4170964B.

MANFACTURER
Blood Bank of Alaska, Anchorage, Alaska.

RECALLED BY
Manufacturer, by telephone and fax on June 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Alaska.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

PRODUCT
Platelets, Pooled. Recall #B-030-9.

CODE
Unit #P64000.

MANFACTURER
Carter Blood Center, doing business as Carter BloodCare, Bedford, Texas.

RECALLED BY
Manufacturer, by letter dated August 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted red blood cells.

PRODUCT
Fresh Frozen Plasma. Recall #B-031-9.

CODE
Unit #12412-4424.

MANFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 18, 1997, followed by letter on July 31, 1997. Firm-initiated recall complete.

DISTRIBUTION
New Mexico.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted red blood cells.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Cryoprecipitate; d) Plasma, Cryo Poor; e) Recovered Plasma. Recall #B-032/036-9.

CODE
Unit numbers: a) KF24046, KF23109, KQ11430, KQ15925, KQ10330; b) KF24046, KQ11430; c) KQ15925, KQ10330; d) KQ15925, KQ10330; e) KF24046, KF23109, KQ11430.

MANFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated September 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Virginia, Switzerland.

QUANTITY
a) 5 units; b) 2 units; c) 2 units; d) 2 units; e) 3 units were distributed.

REASON
Blood products were collected from a donor with a history of jaundice.

PRODUCT
a) Fresh Frozen Plasma; b) Platelets. Recall #B-039/040-9.

CODE
Unit #01LV11764.

MANFACTURER
American Red Cross Blood Services, Buffalo, New York.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by telephone on January 2 and 15, 1998, and or by letter dated January 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products corresponded to a unit of clotted red blood cells.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-042/043-9.

CODE
Unit #KH87772.

MANFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated September 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Virginia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of cancer.

PRODUCT
Red Blood Cells. Recall #B-057-9.

CODE
Unit numbers: FF47286, FF44179, and FF41835.

MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame, California.

RECALLED BY
Manufacturer, by telephone on various dates. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
3 units were distributed.

REASON
Blood products were collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-058/059-9.

CODE
Unit #FF37263.

MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame, California.

RECALLED BY
Manufacturer, by telephone on December 27, 1996. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug, Proscar.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

PRODUCT
Red Blood Cells. Recall #B-038-9.

CODE
Unit #FF-48918.

MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame, California.

RECALLED BY
Manufacturer, by telephone on June 16, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

PRODUCT
Red Blood Cells. Recall #B-041-9.

CODE
Unit #01LV11764.

MANFACTURER
American Red Cross Blood Services, Buffalo, New York.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by telephone on January 2 and 15, 1998, and or by letter dated January 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Blood products corresponded to a unit of clotted red blood cells.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

PRODUCT
Abbott AxSYM B12 Reagent Pack (Dual Pack), list 3C79-20 a microparticle enzyme intrinsic factor assay for the quantitative determination of Vitamin B12 in human serum or plasma on the AxSYM System. Recall #Z-056-9.

CODE
Kit Lot 39039M400 EXP 5/7/98.

MANFACTURER
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois.

RECALLED BY
Manufacturer, by telephone on February 27, 1998 - March 4, 1998, followed by letter dated February 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arkansas, California, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, Vermont, Canada.

QUANTITY
119 kits were distributed.

REASON
The two reagent packs that make up AxSYM B12 Dual Pack have the reagents in the wrong orientation. The reagents that should have been in Reagent Pack A are in Reagent Pack B and vice versa.

PRODUCT
Abbott Vision Chem Controls Kit, list 1433-02 used for verifying the performance of specific Chemistry tests on the Abbott Vision System. Recall #Z-057-9.

CODE
Kit lot 39716M201 EXP 7/19/98.

MANFACTURER
Medical Analysis Systems Inc., Camarillo, California.

RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by "Important Product Information" letters dated 4/13/98. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Japan, Brazil, Australia, Germany and Italy.

QUANTITY
779 kits were distributed.

REASON
The Chem Control I failed high for the Amylase, Cholesterol, Glucose and Triglycerides analytes.

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I

PRODUCT
Horse feed products, in 50 pound bags: a) Farr Better Feeds PERFORM; b) Farr Better Feeds DEVELOP. Recall #V-051/052-8.

CODE
Lot #142.

MANFACTURER
Cargill, Inc./Nutrena Feeds, Stockton, California.

RECALLED BY
Manufacturer, by visit on June 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Arizona, Nevada, Oregon.

QUANTITY
273 bags were distributed.

REASON
Feeds contaminated with salinomycin.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS II

PRODUCT
Non-medicated feeds for layer hens, 25 and 50 lbs bags: a) Blue Seal Layer Pellets; b) Blue Seal Layer Mash. Recall #V-001/002-9.

CODE
a) Code dates 225N8 thru 246N8; b) Code dates 225N8 thru 240N8.

MANFACTURER
Blue Seal Feeds, Inc., Bow, New Hampshire.

RECALLED BY
Manufacturer, by telephone on September 10-11, 1998, followed by visits on September 12, 14, and 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION

New Hampshire, Massachusetts, Maine, Rhode Island, Connecticut.

QUANTITY
a) 162.5 tons; b) 41.0 tons were distributed.

REASON
A complaint of lowered egg production due to the protein level of 10.8% instead of the guaranteed 15% on the feed tag.

END OF ENFORCEMENT REPORT FOR OCTOBER 21, 1998. BLANK PAGES MAY FOLLOW.

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