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FDA RECALLS & COURT ACTIONS: Oct. 7 & 14, 1992

Executive Summary

CLASS II -- BECLOVENT BECONASE BECLOMETHASONE DIPROPIONATE, USP) INHALATION AEROSOL (a) refill; 16.8 grams, 200 metered inhalations, for use with either the Beclovent Oral Adapter or the Beconase Nasal Adapter; (b) 6.7 grams, 80 metered inhalations, for oral inhalation with the beclovent inhalation aerosol adapter; (c) 6.7 grams, 80 metered inhalations, for oral inhalation with the beclovent inhalation aerosol adapter. This 6.7 gram Beclovent is a professional sample, not for sale. Recall number: D-009/010-3. Lot numbers: (a) Z8262DA and Z8272DA EXP May 1994; (b) Z4932BA EXP MAY 1994; (c) Z5072BA, Z5082BA and Z8432DA EXP June 1994. Manufacturer: Glaxo, Inc., Zebulon, North Carolina. Recalled by: Manufacturer, by electronic mail Sept. 1, 1992, and by letters of Sept. 15 and 17, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 61,793 cans were distributed. Reason: Subpotency. CLASS II -- CHLORDIAZEPOXIDE HCl CAPSULES, USP (a) 10 mg; (b) 25 mg, in bottles of 100, 500, and 1,000, a Rx drug with anti-anxiety and sedative actions, under the Pioneer and URL labels. Recall number: D-520/521-2. Lot numbers and EXP dates: (a) 4011-13 EXP 6/92, 4011-14 EXP 11/92, 4011-15 EXP 2/93, 4011-18 EXP 10/93, 4011-19 EXP 11/93, 4011-20 EXP 11/93; (b) 4012-7 9/92, 4012-7A 9/92. Manufacturer: Pioneer Pharmaceuticals, Inc., Irvington, New Jersey. Recalled by: Manufacturer, by letters of March 27, 1992 and April 13, 1992. Firm-initiated recall ongoing. Distribution: Indiana, Maryland, Michigan, Pennsylvania; firm estimates (a) 3,037,000 capsules; (b) 453,000 capsules remain on the market. Reason: Use of unapproved manufacturing procedures. DICYCLOMINE HCl TABLETS, USP 20 mg, in bottles of 100, 500, and 1,000, a Rx anti-spasmodic and anti-cholinergic. Recall number: D-011-3. Lots numbered consecutively 6013-30 through 6013-123. Manufacturer: Pioneer Pharmaceuticals, Inc., Irvington, New Jersey. Recalled by: Manufacturer, by FAX April 9, 1992, and by letter April 13, 1992. Firm-initiated recall ongoing. Distribution: Nationwide and Puerto Rico; 26,846,500 tablets were distributed. Reason: Use of unapproved manufacturing procedures. DIPHENYDRAMINE HCl CAPSULES (a) 25 mg; (b) 50 mg, packaged in bottles of 100, 500, and 1000, a Rx antihistamine, under the Pioneer, Goldline, Rugby, and Bioline labels. Recall number: D-005/006-3. Lot numbers and EXP dates: (a) 4103-35 5/92, 4013-36 6/92, 4013-37 6/92, 4013-38 7/92, 4013-39 8/92, 4013-40 8/92, 4013-41 8/92 4013-42 10/92, 4013-43 10/92, 4013-44 12/92, 4013-45 1/93; (b) 4008-39 6/92, 4008-40 6/92, 4008-41 7/92, 4008-42 8/92, 4008-43 8/92, 4008-44 9/92, 4008-45 12/93. Manufacturer: Pioneer Pharmaceuticals, Irvington, New Jersey. Recalled by: Manufacturer, by telephone May 5, 1992, by FAX May 6, 1992, and by letter May 8, 1992. Firm-initiated recall ongoing. Distribution: (a) Florida, Indiana, Tennessee, Puerto Rico; (b) Florida, Tennessee, Puerto Rico; Firm estimates (a) 5,418,000 capsules; (b) 2,656,000 capsules remain on the market. Reason: Use of unapproved manufacturing procedures. INDOMETHACIN CAPSULES In bottles of 100 and 500, Rx non-steroidal anti-inflammatory, antipyretic and analgesic, under the Pioneer, Major and URL labels: (a) 25 mg; (b) 50 mg. Recall number: D-522/523-2. Lots numbered consecutively (a) 4005-8 through 4005-19; (b) 4006-9 through 4006-15. Manufacturer: Pioneer Pharmaceuticals, Inc., Irvington, New Jersey. Recalled by: Manufacturer, by FAX April 9, 1992, and by letter April 13, 1992. Firm-initiated recall ongoing. Distribution: California, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, New York, Pennsylvania; firm estimates (a) 2,700,000 capsules; (b) 1,580,000 capsules remain on the market. Reason: Use of unapproved manufacturing procedure. RESPORAL TR TABLETS In bottles of 50, 100 and 1,000, a Rx drug under Pioneer, Goldline and Rugby labels. Recall number: D-524-2. Lot numbers and EXP dates: 3003-36 12/92, 3003-41 12/92, 3003-45 9/92, 3003-47 11/92, 3003-48 12/92, 3003-52 3/95, 3003-53 3/95, 3003-54 7/95. Manufacturer: Pioneer Pharmaceuticals, Irvington, New Jersey. Recalled by: Manufacturer, by FAX May 6, 1992 and by letter May 8, 1992. Firm-initiated recall ongoing. Distribution: Florida, Iowa, Maryland, New Jersey, New York; firm estimates 3,465,000 tablets remain on the market. Reason: Use of unapproved manufacturing procedures. CLASS II UPDATE: ADENOCARD Adenocard (adenosine) 3 mg/ml. Recall number: D-398-2, manufactured by Lyphomed, Division of Fujisawa USA, Inc., which appeared in the June 24, 1992 Enforcement Report ("The Pink Sheet" June 29, T&G-10) has been extended to include lot numbers 320340 and 320460. CLASS III -- BRIOSCHI For upset stomach, powder/granules packaged in 8-1/2 ounce bottles and 12 X 6 gm foil packs. Recall number: D-007-3. Returned packages coded: Lot number 92021 EXP 1/97, unopened cases coded 92021. Manufacturer: Brioschi, Inc., Fairlawn, New Jersey. Recalled by: Manufacturer, by visit on or about June 23, 1992 and by FAX June 26, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 8,820 (8-1/2 ounce bottles), and 1,944 (12 x 6 gm foil packs) were distributed; firm estimates 2,600 8-1/2 ounce bottles and 200 foil packs remain on the market. Reason: Presence of trace quantities of sulfides. CLASS III -- FENTANYL CITRATE, USP 5 cc Carpuject prefilled syring, an Rx analgesic. Recall number: D-003-3. Code M500JA EXP July 1993. Manufacturer: Sanofi Winthrop Pharmaceuticals, McPherson, Kansas. Recalled by: Sterling Winthrop, New York, New York, by letter dated Sept. 8, 1992. Firm- initiated recall ongoing. Distribution: Nationwide; 2,266 boxes each containing 10 syringes were distributed. Reason: Some units were found to malfunction not permitting penetration of the rubber stopper. CLASS III -- FULL VALUE AND HEALTH MART BRANDS OF ISOPROPYL RUBBING ALCOHOL 70%, 16 fluid ounces. Recall number: D-001-3. Lot numbers: 126011 and 220631. Manufacturer: Cumberland-Swan, Inc., Smyrna, Tennessee. Recalled by: Manufacturer, by telephone Aug. 26, 1992, by electronic mail Aug. 28, 1992, and by letter Sept. 1, 1992. Firm-initiated recall ongoing. Distribution: Arkansas, Colorado, Florida, Illinois, Louisiana, Missouri, Ohio, Oklahoma, Texas, Wisconsin; 4,804 cases of lot 216001 and 295 cases of lot 220631, 12 bottles per case were distributed. Reason: Label fails to bear indications, ingredients and caution statements. CLASS III -- (a) MHL DECONGESTANT; (b) MHL DECONGESTANT PLUS (a) Pseudoephedrine HCL tablets in 36 and 100 tablet bottles; (b) Pseudoephedrine, 60 mg, Chlorpheniramine Maleate, 4 mg, in 36 and 100 tablet bottles. Recall number: D-003/004-2. Code (a) 8480 11 94; (b) 8510 12 94. Manufacturer: Magno-Humphries, Inc., Tigard, Oregon. Recalled by: Manufacturer, by letter April 24, 1992. Firm-initiated recall ongoing. Distribution: Oregon, Washington state; (a) 2,096 36-count bottles and 7,930 100-count bottles; (b) 372 36-count bottles and 1,002 100-count bottles were distributed. Reason: Presence of a foreign tablet in each product, identified as bisacodyl and biotin. CLASS III -- NORWICH ASPIRIN 325 mg, 100 coated tablets in plastic bottle. Recall number: D-002-3. Lot number 206777 EXP APR 97. Manufacturer: Procter & Gamble Pharmaceuticals, Inc., Norwich, New York. Recalled by: Chattem, Inc., Chattanooga, Tennessee, by letter Sept. 22, 1992, to be followed by visit or telephone. Firm-initiated recall ongoing. Distribution: California, Colorado, Connecticut, Florida, Georgia, Minnesota, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington state, West Virginia, Indiana, Kentucky, Massachusetts; Approximately 1,400 dozen bottles were distributed beginning on 8/26/92. Reason: Incorrect wording in caution statement. CLASS II -- Rx ORAL SOLUTIONS (a) Thioridazine Hydrochloride Oral Solution, USP, 30 mg/ml (Concentrate); 4 fluid ounce amber glass bottles, used for the management of manifestations of psychotic disorders, distributed under PBI, Major, GG labels; (b) Thioridazine Hydrochloride Oral Solution, USP, 100 mg/ml (Concentrate), in 4 fluid ounce amber glass bottles, used for the management of manifestations of psychotic disorders, distributed under PBI, Major labels; (c) Trifluoperazine Hydrochloride Oral Solution (Concentrate) 10 mg/ml, 2 fluid ounce amber glass bottles, used for the management of the manifestations of psychotic disorders, distributed under PBI, W/C Warner Chilcott, UDL labels. Recall number: D-012/014-3. All lots. Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois. Distribution: Nationwide; the firm estimates that (a) 6,800 bottles; (b) 7,400 bottles; (c) 5,300 bottles remain on the market. Reason: Products fail stability specifications for color prior to expiration date. SEIZURE -- AKNE-MYCIN (ERYTHROMYCIN) OINTMENT Charge: Adulterated -- The product purports to be and is represented as a drug, the name of which is recognized in an official compendium, and its strength differs from the standard set forth in such compendium. Firm: Stiefel Laboratories, Inc., Oak Hill, New York. Filed: June 16, 1992; U.S. District Court for the Northern District of New York; Civil number 92-CV-771CGC, FDC number 66453. Seized: June 23, 1992 -- goods valued at approximately $5,780.

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