Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA RECALLS & COURT ACTIONS: Nov. 25, Dec. 2, 9 & 16, 1992

Executive Summary

CLASS I -- IDPN -- INTRADIALYTIC PARENTERAL NUTRITION Recall number: D-067-3. Code: 9/21/92, 9/22/92, 9/28/92 (date compounded). Manufacturer: Washington Clinic Pharmacy, Washington, D.C. Recalled by: Infusion Care Systems, Inc., Mt. Laurel, New Jersey, by visit or by telephone Sept. 29-30, 1992. Firm-initiated recall ongoing. Distribution: Ohio, Maryland, Michigan, Pennsylvania, Washington, D.C.; 62 units were distributed; firm estimates none remains on the market. Reason: Non-sterility. CLASS II -- PSEUDO-GEST PLUS DECONGESTANT PLUS ANTIHISTAMINE In bottles of 100. Recall number: D-073-3. Lot number P8126. Manufacturer: LNK International, Hauppague, New York. Recalled by: Manufacturer, by letter Oct. 9, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 9,876 bottles were distributed. Reason: A bottle labeled Pseudo-gest Plus was found to contain children's chewable aspirin. CLASS II -- Rx VITAMIN ORAL LIQUIDS As follows: (a) Triple-Vita-Flor Drops 0.25 mg, a Rx alcohol-free vitamin packaged in 50 ml plastic bottles with droppers, sold under the following labels: PBI Triple-Vita-Flor Drops 0.25 mg dietary vitamin A, D, C & fluoride supplement infants' drops, Manufactured by: Pharmaceutical Basics, Inc., GG Triplevite with Fluoride dietary vitamin A, D, C & fluoride supplement infants' drops 0.25 mg, Dist. by Geneva Pharmaceuticals, Inc., Pharmacist's Choice Triple-Vita-Flor Infants' Drops, dietary vitamin A, D, C & Fluoride supplement, fluoride 0.25 mg, Pharmacist's Choice, Manufactured by Pharmaceutical Basics, Inc.; (b) Triple-Vita-Flor Drops 0.5 mg, a Rx sugar-free, alcohol-free vitamin packaged in 50 ml plastic bottles with droppers, sold under the following labels: PBI Triple-Vita-Flor Drops 0.5 mg dietary vitamin A, D, C & fluoride supplement infants' drops. Manufactured by: Pharmaceutical Basics, Inc., GG Triplevite with Fluoride dietary vitamin A,D,C & fluoride supplement infants' drops 0.5 mg, Dist. by Geneva Pharmaceuticals, Inc. Recall number: D- 071/072-3. Lot numbers: (a) 18756, 18836, 19055, 19247, 19252; (b) 19035, 19138, 19212, 19329, 19382. Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois. Recalled by: Manufacturer, by letter Nov. 13, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; (a) 355,849 bottles; (b) 31,039 bottles were distributed; firm estimates 33 percent of product remains on the market. Reason: Preservative system not effective through expiration date. CLASS II -- SELENIUM SULFIDE LOTION, USP 2.5%, in 4 fluid ounce bottles, a Rx liquid antiseborrheic, antifungal preparation for topical application for the treatment of dandruff and seborrheic dermatitis, under the following labels: PBI, Bioline, GG, Goldline, Major, H. L. Moore, Qualitest, Rugby, URL. Recall number: D-075-3. All unexpired lots. Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois. Recalled by: Manufacturer, by letter Nov. 20, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, West Indies, Barbados; 633,150 bottles were distributed; firm estimates 40 percent of the product remains on the market. Reason: Preservative system not effective through expiration date. CLASS III -- (a) CORN-STICK; (b) WART STICK (a) 5.10 grams, corn/callus remover; (b) 5.10 grams, wart remover. Recall number: D-076/077-3. All lots. Manufacturer: Balassa Laboratories, Inc., Port Orange, Florida. Recalled by: Manufacturer, by letter Aug. 25, 1992. Firm-initiated recall complete. Distribution: Colorado, New York, Illinois; firm estimates none remains on the market. Reason: Products are not formulated in accordance with OTC monograph for wart/corn remover drugs. CLASS III -- LITERATURE PROMOTING PRO MED's CAPABILITY TO COMPOUND UNIT DOSE BRONCHODILATOR MEDICATIONS Rx new drugs without approved drug applications. Recall number: D- 068-3. All literature distributed. Manufacturer: Pro Med Pharmacies, Amarillo, Texas. Recalled by: Manufacturer, by telephone May 15, 1992. Firm-initiated field correction complete. Distribution: Nationwide; firm estimates none of the literature remains on the market. Reason: Literature promoted firm's capability to compound drugs regarded by FDA as unapproved new drugs. CLASS III -- PROCAINAMIDE HCl EXTENDED-RELEASE TABLETS, USP 500 mg, hospital unit dose, packaged in carton boxes containing 10 blister packs (100 tablets), a Rx cardiac drug. Recall number: D-074- 3. Lot number 40861D EXP 3/93. Manufacturer: Danbury Pharmacal, Inc., Danbury, Connecticut. Recalled by: Schein Pharmaceutical, Inc., Port Washington, New York, by letter Oct. 15, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; firm estimates that less than 100 units, if any at all, remain on the market. Reason: Repackaged product contained package inserts for Procainamide Capsules instead of the insert for Procainamide HCL ER Tablets. CLASS III -- Rx MULTIVITAMIN ORAL LIQUIDS (a) Multi-Vita Drops w/Fluoride 0.25 mg, a Rx sugar-free, alcohol- free vitamin packaged in 50 ml plastic bottles with droppers, sold under the following labels: PBI Multi-Vita Drops with Fluoride 0.25 mg multivitamin & fluoride supplement infants' drops, Manufactured by Pharmaceutical Basics, Inc., GG Polyvite with Fluoride multivitamin & fluoride supplement infants' drops 0.25 mg, Dist. by Geneva Pharmaceuticals, Inc., (b) Multi-Vita Drops w/Fluoride 0.5 mg, a Rx sugar-free, alcohol-free vitamin packaged in 50 ml plastic bottles with droppers, sold under the following labels: PBI Multi-Vita Drops with Fluoride 0.5 mg multivitamin & fluoride supplement infants' drops, Manufactured by Pharmaceutical Basics, Inc., GG Polyvite with Fluoride multivitamin & fluoride supplement infants' drops 0.5 mg, Dist. by Geneva Pharmaceuticals, Inc. Recall number: D-069/070-3. Lot numbers: (a) 19090, 19159, 19264, 19390, 19421 (b) 18904, 19070, 19320, 19392. Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois. Recalled by: Manufacturer, by letter Nov. 13, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; (a) 75,916 bottles; (b) 33,225 bottles were distributed. Reason: Subpotency of Vitamin C ingredient prior to expiration date. CLASS III -- THIAMINE HCL TABLETS USP Recall number: F-111-3. Repacker's lot number 51568; manufacturer's lot number K1055, EXP 11/93. Manufacturer: Life-Line Nutritional Products, Inc., Hayward, California. Recalled by: West-Ward Pharmaceutical Corporation, Eatontown, New Jersey, by letter dated Sept. 4, 1992. Firm-initiated recall ongoing. Distribution: Nationwide and Puerto Rico; 2,448 packages of 100 vitamins were distributed; firm estimates 1,079 packages remain on the market. Reason: Product exceeds USP potency limits. CLASS III UPDATE -- "EXCEL" 0.9% SODIUM CHLORIDE INJECTION "Excel" 0.9% Sodium Chloride Injection U.S.P. in 500 ml plastic containers. Recall number: D-469-2, manufactured by McGaw, Inc., Irvine, California, which appeared in the Sept. 2, 1992 "Enforcement Report" ("The Pink Sheet" Sept. 7, T&G-10) has been extended to include all lots (422 lots) of the product manufactured from 2/14/90 through 6/8/92. Lot numbers J0B718 through J2H462.

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

UsernamePublicRestriction

Register

OM017175

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