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FDA RECALLS & COURT ACTIONS: April 21, 1993

Executive Summary

CLASS II - AMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 ml, 200 ml (when mixed), Rx product used to treat infections, under the following labels: URL, Schein, Goldline, Aligen, Major, Rugby. Recall number: D-218-3. Lot number 27871 EXP 3/1/94. Manufacturer: Biocraft Laboratories, Inc., Elmwood Park, New Jersey. by telephone Sept. 10, 1992, followed by letters of Sept. 14 and 22, 1992. Firm-initiated recall complete. Distribution: New York, Wyoming, Illinois, Kentucky, California, Pennsylvania, Florida; 5,010 bottles were distributed. Reason: Subpotency. CLASS II - BANCAP CAPSULES 50 mg butalbital and 325 acetaminophen, in 100 and 500 capsule bottles, Rx for the relief of the symptoms complex of tension or muscle contraction, headache. Recall number: D-217-3. Lot number 4916 EXP 5/93. Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Forest Pharmaceuticals, Inc., Maryland Heights, Missouri, by letters dated Feb. 1, 1993. Firm- initiated recall ongoing. Distribution: Nationwide; 1,606 100- capsule bottles and 60 500-capsule bottles were distributed. Reason: Unreliable data in the Abbreviated New Drug Application. CLASS III - E.S.P. (ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL) For oral suspension 200 mg/600 mg/5 ml, a Rx antibiotic powder. Recall number: D-219-3. Lot numbers: 1H445DQ EXP 9/95, 1I445EF EXP 10/95. Manufacturer: Barr Laboratories, Inc., Pomona, New York. Recalled by: Manufacturer, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: Subpotency. CLASS II - ERYTHROMYCIN LACTOBIONATE, USP Intravenous sterile, lyophilized powder for reconstitution and injection, used in the treatment of infections. Recall number: D-228-3. Control numbers: 323-807 (2849-01-111), 307-815 (2849-02-111), 3170848 (2848-56-400). Manufacturer: Lederle Parenterals, Carolina, Puerto Rico. Recalled by: Manufacturer, by letter March 22, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 7,320 units (packages of 10) were distributed. Reason: Product fails pH and potency specifications after reconstitution. CLASS III - ASPIRIN WITH CODEINE TABLETS 325 mg/60 mg, a Rx analgesic. Recall number: D-224-3. Lot number 1C280DT EXP 1/96. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: Subpotent. CLASS III - DICYCLOMINE HCL CAPSULES, USP 20 mg, in bottles of 1,000, an antispasmodic and anticholinergic. Recall number: D-227-3. Lot numbers: 0E126AA EXP 7/94 and 1H125CX EXP 9/95. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: Small degrees of superpotency. CLASS III - ERYTHROMYCIN DELAYED-RELEASE CAPSULES 250 mg, a Rx oral antibiotic. Recall number: D-220-3. Lot number 1F584EV EXP 7/93. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: Superpotent. CLASS III - ERYTHROMYCIN STEARATE TABLETS (a) 250 mg; (b) 500 mg, in bottles of 500, oral Rx antibiotics. Recall number: D-221/222-3. Lot numbers: (a) 01013FQ EXP 3/93; (b) 2A219HJ EXP 5/94. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: (a) Small degrees of subpotency. (b) Product does not meet content uniformity specifications. CLASS III - ERYTHROMYCIN ETHYLSUCCINATE TABLETS 400 mg, in bottles of 100, a Rx oral antibiotic. Recall number: D-223-3. Lot number 0B259FA EXP 3/94. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: Product does not meet content uniformity specifications. CLASS III - HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLETS 5 mg/500 mg, in bottles of 100, 50, 20, and 30, an antitussive/analgesic combination. Recall number: D-225-3. Lot number 1D325CL EXP 5/94. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: Superpotent. CLASS III - MEPERIDINE HCL TABLETS 50 mg, in bottles of 100, a narcotic analgesic. Recall number: D-226-3. Lot number 0B381AT EXP 3/93. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letter on or about Feb. 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Undetermined. Reason: Subpotent. CLASS III - TOPICAL HEPARIN POWDER In 55 gallon size fiber drums, used to manufacture topical ointments. Recall number: D-229-3. Lot numbers: TH-182-92, and TH-183-92. Manufacturer: Kabi Pharmacia Hepar, Inc., Franklin, Ohio. Recalled by: Manufacturer, by letter dated Feb. 9, 1993. Firm- initiated field correction ongoing. Distribution: France; 2 drums were distributed. Reason: Product mislabeled as Lithium Heparin.
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