February 19, 1997 97-08 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Neomycin (1.75 mg/ml) and Polymyxin B Sulfates (10,000 units/ml) and Gramicidin (0.025 mg/ml, Ophthalmic Solution, USP, Rx sterile, 10 ml, under the following labels: Akorn - AK-SPOR, Alba - ALBA-3 OPHTHALMIC SOLUTION, Carisle, Geneva, Goldline, IDE-Interstate - TRIBIOTIC, Rugby, Steris, URL, Aligen, Generics of Puerto Rico - TRIPLE ANTIBIOTIC OPHTHALMIC, Major - NEOCIDIN OPHTHALMIC SOLUTION, E. Fougera, Schein. Recall #D-101-7. CODE All lots within expiration date. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letter dated March 18, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY Approximately 1,668,000 units of all lots were distributed. REASON Product lacks stability (i.e. Gramicidin fails potency assay at 18-month stability timepoint -- 80%; SPEC is 90-110%). _______________ PRODUCT B-C-12-1000 (B Complex with C and B12), Lyophilized), for Injection, in 10 ml multidose vials, under the following labels: Carlisle, Clint Pharmaceuticals, Inc. - "VITA-PLEX", Germiphene, Gil Pharmaceutical - "VITAJECT", Goldline, Hyrex - "KEY-PLEX UNIVIAL", IDE - Interstate, International Ethical Lab - "NEUROFORTE-SIX", Jaapharm Canada Inc., Keene Pharmaceuticals - "VICAM (IV)", Key Co., Lambda Pharmacal - "NEURO B12 FORTE", Llorens Pharm Corp., McGuff Co., Medical Products Panamericana - "NEURODEP", Merit, Moore, OTC Pharmaceutical Products - "NEUROBION", R.W. Enterprise (USA), Rugby, Schein, Seyer - "SUPERVITE", Sorter - "NEURIN - BC", Steris, United Research Labs. Recall #D-102-7. CODE All lots within expiration date. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letters dated April 17, 1996, and June 13, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and Japan. QUANTITY Approximately 388,000 units were distributed. REASON Product lacks stability (i.e., Dexpanthenol fails potency assay as early as the 12-month stability timepoint -- 89%; SPEC is 90-110%). _______________ PRODUCT Morphine Sulfate Injection, Rx, USP, (a) 1 mg/ml and (b) 0.5 mg/ml, in 10 ml single dose vials. Recall #D-103/104-7. CODE Lot numbers: (a) 94K200, 94M050, 95E380, 95H610; (b) 94L120, 94L700, 95A010. MANUFACTURER Steris Laboratories, Inc, Phoenix, Arizona. RECALLED BY Manufacturer, by letter dated April 26, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY (a) Approximately 36,000 vials; (b) Approximately 53,000 vials were distributed. REASON Presence of particulate matter. _______________ PRODUCT Chorionic Gonadotropin for Injection, Rx, USP, 10,000 units/10 ml multiple dose vial, distributed under the following labels: Steris, Schein, Carlisle, Goldline, Hyrex - Chorex-10, R.W. Enterprises (USA) - Ovulatone. Recall #D-105-7. CODE All product within expiration date. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. -2-RECALLED BY Manufacturer, by letter dated May 17, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Approximately 147,000 vials were distributed. REASON presence of particulate matter. _______________ PRODUCT Multivitamins for Infusion, Rx, in 10 ml single dose vials, under the following labels: Schein, Steris, Faulding (Canada). Recall #D-106-7. CODE All lots within expiration date. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letter dated April 19, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY Approximately 3 million vials were distributed. REASON Presence of particulate matter. _______________ PRODUCT Heparin Sodium Injection, USP, Rx, used for used for anti-coagulant prophylaxis and treatment, under the following labels - Steris, Schein, Biogen: (a) 1,000 units/ml in 10 ml vials; (b) 20,000 units/ml, in 1 ml and 2 ml vials; (c) 40,000 units/ml, in 1 ml, 2 ml, and 5 ml vials. Recall #D-107/109-7. CODE Lot numbers: (a) 95F780; (b) 96C390 (1 ml), 94E850, 95D740, 95F910 (2 ml); (c) 95K080 (1 ml), 95B190 (2 ml), 95A040, 95B191, 95K081, 95A040 (5 ml). MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letter dated November 4, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and Ukraine. QUANTITY Approximately 34,000 vials of all sizes were distributed. REASON Presence of particulate matter. _______________ PRODUCT Prochlorperazine Edisylate Injection, USP, 10 mg/2 ml, Rx, used for used for the treatment of severe nausea and vomiting, and for the management of the manifestations of psychotic disorders. Recall #D-110-7. CODE Lot numbers: 94F910, 94G570, 94H280, 94H320, 94J400 (All lots within expiration date). MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letters dated January 18, 1996, and February 8, 1996. Firm-initiated recall complete. -3-DISTRIBUTION Nationwide. QUANTITY Approximately 18,500 vials were distributed. REASON Product lacks stability (fails potency assay at the end of expiry). _______________ PRODUCT GoJo brand Hand Medic Antiseptic Skin Treatment, OTC, in 500 ml cartridges. Recall #D-111-7. CODE Batch numbers: 049671, 049672, 049673, 049674. MANUFACTURER Gojo Industries, Inc., Cuyahoga Falls, Ohio. RECALLED BY Manufacturer, by fax sent on January 28-30, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide (to industrial users only). QUANTITY The following amounts of product identified with the referenced stock numbers were distributed: Stock No. 8242-512-R1: 8,184 cartridges; Stock No. 1302-01: 5,760 cases; and Stock No. 8242-06: 220 cases. REASON Subpotent -- Recalled lots do not contain the sole active ingredient, benzalkonium chloride. _______________ PRODUCT Martec brand Piroxicam Capsules, USP, 10 mg, in bottles of 100, Rx indicated for use in arthritis. Recall #D-112-7. CODE 96556-1 EXP 03/01. MANUFACTURER Martec Pharmaceutical, Inc., Kansas City, Missouri. RECALLED BY Manufacturer, by letter dated January 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,347 bottles were distributed between 7/11/97 - 1/23/97. REASON Unit label may lack the prescription legend; insert is correctly labeled. _______________ PRODUCT Ethex brand Hydrocodone Bitartrate and Guaifenesin Liquid, in 16 fluid ounce bottles, Rx for the temporary relief of dry, nonproductive cough associated with upper and lower respiratory tract congestion. Recall #D-116-7. CODE Lot numbers: L8693 and L8696. MANUFACTURER KV Pharmaceutical Company, St. Louis, Missouri. RECALLED BY Ethex Corporation, St. Louis, Missouri, by letter dated January 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. -4-QUANTITY 14,136 bottles of lot L8693 were distributed between 12/23-30/96 and 7,307 bottles of lot L8696 were distributed between January 13-16, 1997. REASON Presence of precipitate (guaifenesin is precipitating due to exposure to low temperatures while warehoused and shipped. _______________ PRODUCT Alcoholado Alcanformentol 70, OTC alcohol 70% (topical liquid), in 12 fluid ounce bottles. Recall #D-117-7. CODE Lot #G07-0794 EXP 11/27/99. MANUFACTURER Specialties Chemical, Inc., Ponce Puerto Rico. RECALLED BY Manufacturer, by visit on January 27, 1997. Firm-initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY 192 bottles were distributed. REASON Incorrect product formulation -- isopropyl alcohol used instead of ethyl alcohol. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-344/345-7. CODE Unit #8145560. MANUFACTURER Carter Blood Center, Fort Worth, Texas. RECALLED BY Manufacturer, by telephone on November 20, 1996. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had been permanently deferred. _______________ PRODUCT Recovered Plasma. Recall #B-349-7. CODE Unit #355079. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by letter dated November 1, 1995. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported an accidental needlestick within 12 months of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma; (e) Platelets, for further manufacture. Recall #B-353/357-7. -5-CODE Unit numbers: (a) 8107974, 8109809, 8116534, 8116938, 8118637, 8120204, 8122411, 8120323, 8125739, 8128055; (b) 8107974, 8116938, 8118637, 8120204, 8120323; (c) 8106846; (d) 8107974, 8109809, 8116534, 8116938, 8118637, 8120204, 8122411, 8120323, 8125739, 8128055; (e) 8122411, 8125739. MANUFACTURER Permian Basin Regional Blood Center, also known as Permian Basin Blood Institute, Midland, Texas. RECALLED BY Manufacturer, by letter dated September 30, 1995. Firm-initiated recall complete. DISTRIBUTION Texas, Colorado. QUANTITY (a) 10 units; (b) 5 units; (c) 1 unit; (d) 10 units; (e) 2 units were distributed. REASON Blood products tested negative for HBsAg were collected from donors who reported histories of jaundice, liver disease, or hepatitis, or were subsequently collected from these donors. _______________ PRODUCT Red Blood Cells. Recall #B-372-7. CODE Unit numbers: 49J66132, 49J66819. MANUFACTURER American National Red Cross, Norman, Oklahoma. RECALLED BY Manufacturer, by letter dated June 18, 1996. Firm-initiated recall complete. DISTRIBUTION California and Oklahoma. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who traveled to an area designated as endemic for malaria. _______________ PRODUCT Source Plasma. Recall #B-373-7. CODE FP57388, FP57333, FP57233, FP57188, FP57041, FP56981, FP56952, FP56897, FP56851, FP56809, FP56752, FP58712, FP56674, FP56621, FP56589, FP56522, FP56489, FP54195, FP53959, FP53817, FP53629, FP53590, FP53514, FP53474, FP53353, FP53291, FP53181, FP53125, FP52926, FP51289, FP51784, FP51584, FP51182, 52459788, 52458088, 52454943, 52450839, 52438585, 52436956, 52435447, 52433634, 52431913, 52417740, 52415908, 52413667, 52412158, 52099120, 52097645, 52095504, 52094231, 52091230, 49809695, 49806854, 49805280, 49802788, 49801682, 49469509, 49467857, 49464979, 47485167, 47482593, and 47480773. MANUFACTURER Interstate Blood Bank, Inc., of WI, Milwaukee, Wisconsin. -6-RECALLED BY Interstate Blood Bank, Inc., Memphis, Tennessee, by telephone on February 15, 1996, followed by letter. Firm-initiated recall complete. DISTRIBUTION California and Germany. QUANTITY 62 units were distributed. REASON Blood products tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), were collected from a donor who had previously tested repeatedly reactive for anti-HCV. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-374/375-7. CODE Unit #2838997. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated July 26, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who traveled to a malarial endemic area. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-378/380-7. CODE Unit #2850080. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter July 26, 1996. Firm- initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who received ear piercing within twelve months of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-383/384-7. CODE Unit #KR93443. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by telephone on October 22, 1996, and by letter dated November 14, 1996. Firm-initiated recall complete. DISTRIBUTION Louisiana and California. QUANTITY 1 unit of each component. -7-REASON Blood products were collected from a donor taking the drug Proscar. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Platelets, Pheresis. Recall #B-323-7. CODE Unit numbers 32P16021 and 32P16243. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated March 27, 1996. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 2 units were distributed. REASON Blood products tested initially reactive for the hepatitis B surface antigen (HBsAg), and were not retested in duplicate, or which tested negative for HBsAg, were collected from a donor who was previously tested incorrectly for HBsAg. _______________ PRODUCT Recovered Plasma. Recall #B-339-7. CODE Unit numbers: 30G04947, 30N20313, 30H60926, 30X51767, 30H42151. MANUFACTURER American Red Cross Blood Services, Ashley, Pennsylvania. RECALLED BY Manufacturer, by letter on July 19, 1995. Firm-initiated recall complete. DISTRIBUTION New York California, Switzerland. QUANTITY 5 units were distributed. REASON Blood products tested negative for the hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested repeatedly reactive for HBsAg. The donor has met reentry. _______________ PRODUCT Platelets. Recall #B-346-7. CODE Unit numbers: 4701001, 4701002, 4701003, 4701004, 4701007, 4701008, 4701010, 4701011, 4701998, 4701999. MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on July 1, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 10 units were distributed. REASON Blood products were labeled with an extended expiration date. -8-_______________ PRODUCT Red Blood Cells. Recall #B-350-7. CODE Unit #416402. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by telephone on July 10, 1996. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-351-7. CODE Unit #387972. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by letter dated August 6, 1996. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood product tested reactive for syphilis by RPR. _______________ PRODUCT Platelets. Recall #B-352-7. CODE Unit numbers: 5593331 and 5593341. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on August 7, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 2 units were distributed. REASON Blood products were not stored under continuous agitation. _______________ PRODUCT Platelets. Recall #B-358-7. CODE Unit numbers: 2645245 and 4109025. MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on September 29, 1995, and by letter dated october 9, 1995. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 2 units were distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Source Leukocytes; (d) Recovered Plasma. Recall #B-359/362-7. -9-CODE Unit #2455593. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated July 26, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tissue transplant (eye implant) within a year of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-363/365-7. CODE Unit #2958623. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated July 26, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana, Missouri, New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who previously tested positive for syphilis. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-366/369-7. CODE Unit numbers: (a) 2947365, 3708945, 2938592; (b) 2947365; (c) 2947365; (d) 3708945, 2938592. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated July 26, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana, Missouri, New Jersey. QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit; (d) 2 units were distributed. REASON Blood products were collected from a donor who previously tested positive for gonorrhea. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-370/371-7. CODE Unit #2463162. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated July 26, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana, New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of venereal disease. -10- RECALLS AND FIELD CORRECTIONS: RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Acoma Overhead Tube Support Model A90000-9, a fully counter-balanced heavy-duty radiographic x-ray tube suspension system. Recall #Z-240-7. CODE Serial numbers 05010194001 through 05010895018; All units shipped between 1/26/94 and 9/30/95. MANUFACTURER Acoma Medical Imaging, Inc., Wheeling, Illinois. RECALLED BY Manufacturer, by sending Equipment Field Modification Bulletin No. 97-01-OTS-001, Acoma Recall #1451001-1996-00001, on January 21, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 136 units were distributed. REASON Screw heads may come off and allow the plate at the end of the bridge to fall off. _______________ UPDATE Medtronic Indura Model 8703W Intraspinal Catheter, Recall #Z-223-7 which appeared in the February 12, 1997 Enforcement Report has been updated to include an additional lot number, 41524. Quantity should read: 1,196 catheters were distributed. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT BVS Blood Pump, used with the Abiomed BVS 5000 Bi-Ventricular Support Systems. Recall #Z-222-7. CODE Control numbers beginning with G96, H96, I96, J96, D96 (Only part of D96 is affected: Pumps with control numbers ending in P48, P50, P51, P52, P54, P55, and P56) and E96, F96. MANUFACTURER Abiomed, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer, by letter on November 7, 1996, and by fax on January 30, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide, Japan, Netherlands, Switzerland. QUANTITY 321 units were distributed. REASON The pump is subject to leakage which occurs at the outflow connector (bottom of the pump). _______________ PRODUCT Chartr ENG System, a computer based electronystagmograph used as a diagnostic tool. Recall #Z-252-7. -11-CODE All units shipped prior to 11/22/96. MANUFACTURER ICS Medical Corporation, Schaumburg, Illinois. RECALLED BY Manufacturer, by letter dated November 22, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Egypt, Wales, Portugal, England, Canada. QUANTITY 32 units were distributed. REASON The keyboard will lock up if a certain sequence of keys is entered. -12- END OF ENFORCEMENT REPORT FOR FEBRUARY 19, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for