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FDA RECALLS & COURT ACTIONS: June 17 & 24, 1992

Executive Summary

CLASS II -- ADENOCARD (ADENOSINE), Rx STERILE CARDIAC SOLUTION 3 mg/ml, in 2 ml single dose vials, 10 vials per shelf carton. Recall number: D-398-2. Lot number 311319. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recalled by: Fujisawa Pharmaceutical Company, Division of Fujisawa USA, Inc., Deerfield, Illinois, by letter June 9, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 73,010 vials were distributed; firm estimates 11 percent remains on the market. Reason: The vials have a low fill volume. CLASS II -- CEPHRADINE CAPSULES, USP 250 mg and 500 mg, prompt release capsules, packed 24 and 100 capsules/bottle as well as 100 capsules/blister, a Rx semisynthetic cephalosporin antibiotic, oral dosage form, in capsules containing 250 mg or 500 mg cephradine. The products were packaged and distributed by Biocraft Laboratories, Inc., under the following labels, sizes, and strengths: 250 mg, 100's: Biocraft, Qualitest, Rugby, Geneva, H. L. Moore, United Research, Best Generic, Bioline, Goldline, Warner-Chilcott, Schein; 500 mg, 100's: Biocraft, UDL Lab, Warner-Chilcott, Drug Guild, Qualitest, Major, Bioline, H. L. Moore, Goldline, Rugby, Geneva, Harber; 250 mg, 24's: Biocraft, Schein,; 500 mg, 24's: Biocraft, Schein, Geneva, Goldline. Recall number: D- 381/382-2. Lot number/Potency/Package Sizes/EXP dates: 51129/500 mg/24's, 100's, Blister Packs/3/1/93; 51152/250 mg/24's, 100's/3/1/93; 51189/500 mg/100's/4/1/93; 51190/500 mg/100's/4/1/93; 51210/500 mg/100's/5/1/93; 51212/250 mg/100's/5/1/93; 51213/250 mg/24's, 100's/5/1/93; 51223/250 mg/100's/5/1/93; 51224/500 mg/24's, 100's/3/1/93. Manufacturer: Biocraft Laboratories, Inc., Fairfield, New Jersey. Recalled by: Manufacturer, by telephone Feb. 24-28, 1992, followed by letter March 11, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. Approximately 10,220,360 tablets were distributed; firm estimates 15 percent remains on the market. Reason: not assured through expiration date. CLASS II -- CLINDAMYCIN PHOSPHATE INJECTION, USP 150 mg/ml, equivalent to 150 mg Clindamycin, in 2 ml, 4 ml, and 6 ml single dose vials, a Rx IM or IV injectable antibiotic. Recall number: D-378-2. Lot numbers: 911009, 911029, 911006, 911032, all of which have EXP 4/93. Manufacturer: Smith & Nephew SoloPak, Elk Grove Village, Illinois. Recalled by: Manufacturer, by letter May 29, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 97,575 vials were distributed; firm estimates 30 percent remains on the market. Reason: Potency of product not assured through expiration date. CLASS II -- PROLOID (THYROGLOBULIN TABLETS, USP) A Rx preparation used as a replacement or supplemental therapy in patients with hypothyroidism: 0.5 grain (32 mg) 100's; 1.0 grain (65 mg) 100's/1000's; 1.5 grain (100 mg) 100's; 2.0 grain (130 mg) 100's; 3.0 grain (200 mg) 100's. Recall number: D-383/387-2. All lots. Manufacturer: Parke-Davis Division of Warner-Lambert Company, Vega Baja, Puerto Rico. Recalled by: Parke-Davis Division of Warner- Lambert Company, Morris Plains, New Jersey, by letter Dec. 27, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 2,363,249 bottles were distributed; firm estimated that 6,000 bottles remained on the market as of January 1992. Reason: Potency not assured through expiration date. CLASS II -- VARIOUS Rx INJECTABLE DRUG PRODUCTS (a) M.V.C. 9 + 4 (Pediatric) Multivitamin Concentrate for Infusion, a Rx sterile, lyophilized product for reconstitution and dilution, in 10 ml amber single dose vials, 25 vials per case; (b & c) Nalbuphine Hydrochloride Injection; a Rx sterile analgesic for IM, IV and SC use for the relief of moderate to severe pain, 10 mg/ml, in 1 ml single dose vials, 10 vials per tray; 10 ml multiple dose vials; 20 mg/ml, in 1 ml single dose vials, 10 vials per tray, 10 ml multiple dose vials; (d) Haloperidol Injection, USP, 5 mg/ml, an Rx sterile psychopharmacologic agent for intramuscular use, in 1 ml vials, and in 10 ml multiple dose vials; (e & f) Ritodrine Hydrochloride Injection, USP, a Rx sterile smooth muscle relaxant: 10 mg/ml, in 5 ml vials, 10 vials per tray; 15 mg/ml, in 10 ml vials, 10 vials per tray; (g) Zinc Sulfate Injection, USP, 1 mg/ml; a Rx trace element additive, 10 ml, a single dose vial, and in 30 ml multiple dose vials. Recall number: D-389/395-2. All lots within expiration date. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois. Recalled by: Manufacturer, by letter June 1, 1992. Firm-initiated recall ongoing. Distribution: Nationwide and international. (a) 300,500 vials were distributed; firm estimates none remains on the market; (b&c) 366,649 vials were distributed, with the firm estimating that 91,000 vials remain on the market; (d) 262,181 vials were distributed, with the firm estimating that 122,000 vials remain on the market; (e&f) 34,840 vials were distributed, with the firm estimating that 13,000 vials remain on the market; (g) 190,150 vials were distributed, with the firm estimating that 40,000 vials remain on the market. Reason: Lack of assurance of bioequivalence and ANDA discrepancies. CLASS II - UPDATE Various injectable drug products, manufactured by Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recall number: D- 365/371-2, which appeared in the June 10 Enforcement Report ("The Pink Sheet" June 15, T&G-14) has been extended as follows: Heparin Sodium Injection, 5,000 USP units has been extended to include lot number 320179 EXP 2/94 and Sodium Chloride Injection, USP, 0.9% has been extended to include lot number 320140 EXP 1/94. CLASS III -- DARVON BRAND PROPOXYPHENE HYDROCHLORIDE, USP Packaged in blister packages with 10 capsules to a strip and 10 strips per carton (100 capsules per carton). Recall number: D-396-2. Lot number 5CZ50M blister packs in cartons. Other similar lot numbers in bottles are not under recall. Manufacturer: Eli Lilly Industries, Inc., Carolina, Puerto Rico. Recalled by: Eli Lilly and Company, Indianapolis, Indiana, by letter May 8, 1992. Firm- initiated recall ongoing. Distribution: Nationwide; 1,039 packages were distributed. Reason: The cartons are correctly labeled. The blister strips are incorrectly labeled as Propoxyphene Napsylate. CLASS III -- DIPYRIDAMOLE TABLETS, USP 50 mg, in 1000 tablet bottles, a Rx vasodilator. Recall number: D- 380-2. Lot number 1002033 EXP 12/92. Manufacturer: Sidmak Laboratories, Inc., East Hanover, New Jersey. Recalled by: Manufacturer, by letter mailed March 12, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico. 1,879, 1,000-bottles were distributed; firm estimates little, if any product remains on the market. Distribution: Product does not meet dissolution specifications. CLASS III -- LIQUIPHARM SENNA-RELIEF SYRUP In 2 fluid ounce brown glass bottles, an OTC combination liquid cathartic. Recall number: D-379-2. Code OC2 EXP 3/92, OL2 EXP 10/92. Manufacturer: Liquidpharm Inc., Los Angeles, California. Recalled by: Manufacturer, by undated letter Feb. 28, 1992. Firm-initiated recall ongoing. Distribution: Arizona, California, Colorado, Illinois, Kentucky, Wyoming, Puerto Rico, Belgium. 350 bottles were distributed. Reason: Label lacks alcohol content statement. CLASS III -- NYLIDRIN TABLETS, USP 6 mg, in 100 and 1000 tablet bottles, a Rx vasodilator, under the following labels: Zenith, Goldline, Major, Bioline, H. L. Moore. Recall number: D-388-2. Lot number 2348-070 EXP 6/92. Manufacturer: Zenith Laboratories, Inc., Northvale, New Jersey. Recalled by: Manufacturer, by letter mailed Nov. 8, 1991. Firm-initiated recall ongoing. Distribution: Arizona, California, Florida, Kentucky, Illinois, Michigan, Louisiana, Pennsylvania, Ohio, Tennessee, New York, South Carolina, Massachusetts, Connecticut, Puerto Rico. 950,000 tablets were distributed. Reason: Potency not assured through expiration date. CLASS III -- UPDATE Americaine Hemorrhoidal Ointment (benzocaine 20%) in 1/4 ounce (physician's sample), in ounce and 1-1/3 ounce tubes, Recall number: D-356-2 which appeared in the June 10, 1992 Enforcement Report ("The Pink Sheet" June 15, T&G-15) includes only material distributed on or after Aug. 1, 1991. SEIZURE -- VARIOUS ARTICLES OF DRUG (91-645-201, et al) Charge: New drug -- One product has no approved new drug application in effect. Misbranded -- One product is in package form and fails to bear a label containing the name and address of the manufacturer, packer, or distributor as required by regulation; another product fails to bear a label containing all required words, statements, and other information in the English language, as required by regulation; some of the products are fabricated from two or more ingredients and their labels fail to bear the established name and quantity of each active ingredient; and the products are prescription drugs and their label fails to bear the prescription legend. Firm: International Wholesale Corporation, N.E., Washington, D.C. Filed: May 1, 1992 -- U.S. District Court for the District of Columbia; Civil number 92-1039, FDC number 66372. Seized: May 11, 1992 -- goods valued at approximately $17,000.
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