January 8, 1997 97-2 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Snack mixes in 25 pound boxes: (a) Melrose Mix; (b) Oriental Mix; (c) Snack Mix with Pretzels. Recall #F-161/163-7. CODE Dates of manufacture stamped on bulk box label: 5-1-96 to 11-4-96. MANUFACTURER Texas Pecan Company, Dallas, Texas. RECALLED BY Manufacturer, by letter on December 20, 1996. Products were relabeled on November 4, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY Melrose Mix - 4450 lbs. Oriental Mix - 3500 lbs. Snack Mix with Pretzels - 5000 lbs. REASON Products contain undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Trasylol (aprotinin injection) sterile solution for intravenous infusion, packaged in 200 ml stoppered glass vials, used during coronary artery bypass graft surgery. Recall #D-073-7. CODE Lot 6CCY EXP 11/97, 6FAH EXP 11/97, 6HAG EXP 12/97. MANUFACTURER Bayer A.G. Leverkusen, Germany. RECALLED BY Bayer Corporation, West Haven, Connecticut, by letter on December 17 and 23, 1996. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 15,442 vials of lot 6CCY, 7,392 vials of lot 6FAH, and 9,882 vials of lot 6HAG were distributed. REASON Lack of adequate assurance of sterility. Aluminum skirt holding vial may not be adequately crimped in place. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Viramune (nevirapine) Tablets, 200 mg, packaged in bottles of 100, and in unit dose blisters of 10 cards, 10 tablets per card, Rx, used in combination with other antiretroviral agents for the treatment of HIV-1 infected adults who have experienced clinical and/or immunologic deterioration. Recall #D-061-7. CODE Lot numbers: NS816A EXP 12/98, NS816AX EXP 12/98, NS852A EXP 1/99, NS852B EXP 7/98. MANUFACTURER Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut. RECALLED BY Roxane Laboratories, Inc., Columbus, Ohio (distributor), by letter on November 22, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 13,043 bottles of 100 tablets and 380 cartons of 10x10 blister packs were distributed; firm estimated that 50 percent of product remained on market at time of recall initiation. REASON Dissolution failure (average of 74%; SPEC is NLT 75%). _______________ PRODUCT Oxygen, Compressed USP, transfilled into D or E compressed medical gas cylinders. Recall #D-062-7. -2-CODE The following lot numbers were transfilled during the period of 1/4/96 through 10/16/96: 3376004 33760046 3376036 3376061 6526031 3376050 33753555 3376067 3376073 3376095 6525285 65253204 3376088 3376073 3376116 3376138 3376113 3372599 3376131 3376158 3376179 0546151 0546172 6525320 3376201 3376205 0546219 3376240 3376233 3376249 3376264 3376270. MANUFACTURER Hammer Medical Supply, Inc., Clive, Iowa. RECALLED BY Hammer Medical Supply, Inc., Des Moines, Iowa, by visit beginning on or about October 24, 1996. Firm-initiated recall ongoing. DISTRIBUTION Iowa. QUANTITY Approximately 400 cylinders were in the field at time of recall initiation. REASON Lack of complete and accurate label information (e.g. incorrect lot number). _______________ PRODUCT PanMist S, Guaifenesin Orange-Flavored Syrup, produced by Sage Laboratories, Inc. from December, 1995 through April, 1996, and packaged under the Pan American Laboratories Label. Recall #D-063-7. CODE Lot numbers: SL410SU, SL411SU, SL412SU, S5002, S5106, S6015, S6031, SL413SU, S5001, S5113. MANUFACTURER Sage Pharmaceuticals, Inc., Shreveport, Louisiana. RECALLED BY Manufacturer, by fax on November 22, 1996, followed by letter sent on November 25, 1996. Firm-initiated recall ongoing. DISTRIBUTION Louisiana. QUANTITY Lot Number Packaging Size Number Bottles SL410SU Pint Bottles 1536 SL411SU Pint Bottles 1512 SL412SU Pint Bottles 1505 S5002 Pint Bottles 1554 S5106 Pint Bottles 1260 S6015 Pint Bottles 1560 S6031 Pint Bottles 1560 10487 TOTAL SL413SU 15 ml Sample Bottles 42552 S5001 15 ml Sample Bottles 50544 S5113 15 ml Sample Bottles 46368 139464 TOTAL. REASON Guaifenesin may precipitate. -3-_______________ PRODUCT Intal Inhalers, cromolyn sodium, 200 metered dose size and 112 metered dose size, Rx, used for management of bronchial asthma. Recall #D-064-7. CODE DT6G EXP 5/97 (200 metered size); CK9G EXP 5/97 EXP 5/97, CK10G EXP 6/97 (112 metered size). MANUFACTURER 3M Health Care (Riker Labs), Loughborough, England. RECALLED BY Rhone Poulenc Rorer, Collegeville, Pennsylvania, by letter followed by telephone. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 197,835 units were distributed. REASON Product failed leakage rate test at the 12- month stability testpoint due to faulty stem diaphragm in valve. _______________ PRODUCT Rhone-Poulenc Rorer's (a) Regroton Tablets (Chlorthalidone, 50 mg and Reserpine, 0.25 mg); Demi-Regroton Tablets (Chlorthalidone 25 mg and Reserpine 0.125 mg), used for the management of hypertension. Recall #D-065/066-7. CODE Lot numbers EXP Date (a) MN 1399 6/30/00 MN 0845 4/30/99 MN 0653 11/30/98 MN 0489 6/30/98 MN 0179 3/31/97 MN 0178 3/31/97 MN 0084 3/31/97 MN 1611 6/30/97 (b) MN 1286 3/31/00 MN 0654 6/30/98 MN 0490 6/30/98 MN 0249 2/28/97 MN 0082 2/28/97. MANUFACTURER Rhone Poulenc Rorer Pharmaceutical, Inc., Manati, Puerto Rico. RECALLED BY Rhone Poulenc Rorer Pharmaceuticals, Inc., Collegeville, Pennsylvania., by letter, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 192,932 bottles were distributed. REASON Reserpine is from an unapproved supplier. -4-_______________ PRODUCT Cimetidine Tablets, USP, 800 mg, an oral Rx drug used in the short-term treatment of active duodenal ulcers or active benign gastric ulcers, maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcers, erosive gastroesophageal reflux disease, and the treatment of pathological hypersecretory conditions, packaged under the following labels and package sizes: i) Novopharm, in 100, 500, and 1000 tablet bottles; ii) Warrick Pharmaceuticals, in 100, 500, and 1000 tablet bottles. Recall #D-067-7. CODE Lot #101981 EXP 7/98 (Note: the lot number has various suffixes, dependent on the bottle size). MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada. RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by letter dated November 22, 1996. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 5,549 bottles of 100 tablets, 519 bottles of 500 tablets and 91 bottles of 1000 tablets were distributed; firm estimated that very little, if any product remained on market at time of recall initiation. REASON Product fails dissolution at the 3-month stability timepoint. _______________ PRODUCT Cytovene (Ganciclovir) Capsules, 250 mg, in 180 count bottles, used for management treatment of cytomegalovirus virus. Recall #D-068-7. CODE Lot #B0088 (packaged lot B0418). MANUFACTURER Syntex Puerto Rico, Inc., Humacao, Puerto Rico. RECALLED BY Hoffmann-La Roche, Inc., Nutley, New Jersey, by telephone on July 29, 1996, followed by letter August 1996, and telephone. Firm- initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 8,000 bottles were distributed; firm estimates none remains on the market. REASON Product fails dissolution at the 6-month stability timepoint (64%; SPEC is NLT 70%). -5-_______________ PRODUCT 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, in 1000 ml infusion bags, used for the prevention or treatment of potassium depletion. Recall #D-069-7. CODE J6D410 and J6D414 EXP dates 10/98. MANUFACTURER McGaw, Inc., Irvine, California. RECALLED BY Manufacturer, by letter dated June 18, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 44,364 units were distributed. REASON Container label may not bear the following red-boxed information which highlights the concentration of potassium: "20 mEq K+/liter". _______________ PRODUCT Zestoretic (Lisinopril & Hydrochlorothiazide) 12.5 mg Tablets, used for the management of hypertension. Recall #D-070-7. CODE 3657W EXP 11/1/97, 3604W EXP 11/1/97, 4135 EXP 5/1/98, 4136W EXP 11/1/98. MANUFACTURER IPR Pharmaceuticals, Carolina, Puerto Rico. RECALLED BY Zeneca Pharmaceuticals, Wilmington, Delaware, by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY Firm estimated that 3,200 cases (307,200 blisters) remained on market at time of recall initiation. REASON The rear blister pack label incorrectly states the hydrochlorothiazide potency as 25 mg. The correct potency of 12.5 mg is also stated in several other spots on the label. _______________ PRODUCT Nitrostat Sublingual Tablets (Nitroglycerin Tablets USP), Rx, indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease: (a) 0.4 mg bottles of 25; (b) 0.3 mg bottles of 100. Recall #D-071/072-7. CODE Lot numbers: 00645F EXP 3/97 (bottles of 25); 10325F EXP 1/97 (bottles of 100). MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico. RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris Plains, New Jersey, letter dated December 6, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 23,369 bottles of 25 tablets and 22,413 bottles of 100 tablets were distributed. -6-REASON Lot 00645F failed content assay at the 18- month stability timepoint. Lot 10325F may not meet assay specifications through its shelf- life. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-154-7. CODE Unit numbers: 53FR54013, 53FR54015, 53FR54016. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on August 21, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland and District of Columbia. QUANTITY 3 units were distributed. REASON Blood products were stored at an unacceptable temperature. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-160/161-7. CODE Unit #40FE26117. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letters dated April 19, 1996, and May 1 and 31, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV 1), with no Western blot performed. _______________ PRODUCT Red Blood Cells. Recall #B-176-7. CODE Unit #42FH38315. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated June 30, 1995. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. _______________ PRODUCT Recovered Plasma. Recall #B-189-7. CODE Unit numbers: 30H95505, 30G96070, 30H19540, 30G10284, 30G14890, 30H47468. -7-MANUFACTURER American Red Cross Blood Services, Ashley, Pennsylvania. RECALLED BY Manufacturer, by letter dated July 19, 1995. Firm-initiated recall complete. DISTRIBUTION New York and Switzerland. QUANTITY 6 units were distributed. REASON Blood products tested negative for antibody to the human immunodeficiency virus type 1 (anti- HIV-1), were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, expired; (c) Platelets; (d) Fresh Frozen Plasma; (e) Cryoprecipitated AHF; (f) Single Donor Plasma; (g) Recovered Plasma. Recall #B-190/196-7. CODE Unit numbers: 42FY13174, 2FJ39490, 42FY14464, 42L84260, 42X16113, 42Q54651, 42FK36355, F2FJ25215, 42FY13570, 42T57814, 42L42153, 42FP10240, 42T84632, 42FZ16704, 42FJ35562, 42FJ20057, 42Q11776, 42W32247, 42S96138, 42Y32607, 42FY18011, 42X72864, 4249570, 42R96523, 42FH21494, 42FX27494, 42L07263, 42FY22239. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter sent on December 7, 1995, and January 22, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio, Missouri, Minnesota, Florida, California, Switzerland. QUANTITY (a) 25 units; (b) 1 unit; (c) 8 units; (d) 1 unit; (e) 4 units; (f) 1 unit; (g) 25 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot indeterminate. _______________ PRODUCT Red Blood Cells. Recall #B-197-7. CODE Unit numbers: 49J27331, 49K74362, 49K74363, 49K74364, 49K74367, 49K74372, 49K74379, 49K74380, 49K74395, 49K74405, 49K74407, 49K74409, 49K74411, 49K78897, 49K78944, 49K82062, 49K86476. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. -8-RECALLED BY Manufacturer, by letter dated January 4, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 17 units were distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1) were subjected to additional retesting which was negative; or tested negative for anti-HIV-1, but were collected from donors who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-198/199-7. CODE Unit #21F46599. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letters dated January 16 and 17, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1) were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT (a) Red Blood Cells and Red Blood Cells Deglycerolized; (b) Cryoprecipitated AHF; (c) Recovered Plasma. Recall #B-200/202-7. CODE Red Blood Cells, Cryoprecipitated AHF, and Recovered Plasma Unit #21G94955; Red Blood Cells, Deglycerolized, and Recovered Plasma, Unit #21K93391. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letters dated January 16 and 19, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon and Switzerland. QUANTITY (a) 1 unit each; (b) 1 unit; (c) 2 units of each component were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1) were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT Platelets. Recall #B-203-7. CODE Unit #11313-5867. MANUFACTURER United Blood Services, El Paso, Texas. -9-RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 23, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed REASON Blood product was prepared from a unit of Whole Blood with an extended collection time. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Single Donor Plasma. Recall #B-204/206-7. CODE Unit #2956113. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax on May 31, 1996. Firm- initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who admitted to high risk behavior within the last 12 months. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-207/209-7. CODE Unit #42J64956. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letters of December 8, 1995, July 5 and 10, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1) were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot indeterminate. _______________ PRODUCT (a) Red Blood Cells;(b) Platelets; (c) Recovered Plasma. Recall #B-210/212-7. CODE Unit #042L56615. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter on November 20, 1995. Firm-initiated recall complete. DISTRIBUTION Ohio, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tattoo within 12 months of donation. -10-_______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-213/214-7. CODE Unit numbers: 49F81437, 49X30113, 49W13973. MANUFACTURER American National Red Cross, Tulsa, Oklahoma. RECALLED BY Manufacturer, by letters dated March 20, 1996, May 20, 1996, and June 26, 1996. Firm- initiated recall complete. DISTRIBUTION Texas, Oklahoma. QUANTITY 3 units of each component were distributed. REASON Blood products were collected from donors who traveled to an area designated as endemic for malaria. _______________ PRODUCT Platelets, Pheresis. Recall #B-215-7. CODE Unit #29133-9163. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter on July 25, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area designated as endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Leukocytes Removed; (c) Platelets. Recall #B-216/218-7. CODE Unit numbers: (a) 11314-0898; (b) 11313-5659; (c) 11313-5659. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated August 28, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to areas designated as endemic for malaria. _______________ PRODUCT AS-1 Red Blood Cells. Recall #B-219-7. CODE Unit #23132-8322. MANUFACTURER United Blood Services, Billings, Montana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated September 9, 1996. Firm- initiated recall complete. DISTRIBUTION Montana. QUANTITY 1 unit was distributed. -11-REASON Blood product was collected from a donor who traveled to an area designated as endemic for malaria. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Staphytect-OD Latex Staphylococcus Aureus Test, for in-vitro diagnostic use, Stock #50050. Recall #Z-196-7. CODE Lot #103006 EXP 8/31/97. MANUFACTURER Unipath Limited, Basingstoke, Hants, England. RECALLED BY Orion Diagnostica, Inc., Somerset, New Jersey, by telephone from October 18-22, 1996. Firm- initiated recall ongoing. DISTRIBUTION Illinois, Indiana, Missouri, Maryland, New York, Pennsylvania, Texas, Washington state, Wisconsin. QUANTITY 48 kits were distributed. REASON The reagents in the kit are deteriorating, leading to false positive reactions with Staphylococcus epidermidis, ATC 12228 and some auto-agglutination. -12- END OF ENFORCEMENT REPORT FOR JANUARY 8, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for