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

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.