Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS021628

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel