FDA Recalls & Court Actions: July 11, 1990

CLASS III -- (a) BACTERIOSTATIC WATER FOR INJECTION, USP; (b) CHORIONIC GONADOTROPIN FOR INJECTION, USP; (c) CYTARABINE USP; (d) CYTARABINE USP; (e) GLUCOGAN FOR INJECTION USP (a) In 16 ml multi-dose vials, for use in reconstituting methylprednisolone sodium succinate; (b) A gonal stimulating agent; (c) (sterile), 100 mg, w/Diluent, in 10 ml vials, an anti-neoplastic agent for IV and subcutaneous use only; (d) (sterile) 500 mg w/Diluent in 15 ml, vials, an anti-neoplastic agent for IV and subcutaneous use only; (e) w/Diluent, in 3 ml vials, an anti-diabetic drug for IM, IV or subcutaneous use only. Recall number: D-307/311-0. Lot numbers and EXP dates: (a) 051H47B 11/91; (b) 411J15 10/90, 411J29 01/91, 051J13A 3/92, 051J13A 3/91; (c) 219H51 6/90, 219J12 9/90, 219J17 10/90, 219J29 1/91, 219J44 5/91, 051H04 1/91, 051G52A 12/90, 051J13B 3/92. (d) 220J12 9/90, 220J22 12/90, 220J29 1/91, 051H47A 11/91, 051J13A 3/92; (e) 435H52 5/90, 435H52 6/90, 435J07A 8/90, 435J07B 7/90, 435J18 7/90, 435J19 7/90, 435J22 11/90, 435J24 11/90, 435J25 11/90, 437H45 5/90, 437J02 7/90, 437J11 9/90, 437J02 7/90, 437J18 11/90. Manufacturer: Quad Pharmaceuticals, Indianapolis, Indiana. Recalled by: Manufacturer, by letter June 11, 1989. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 305 vials; (b) 45,584 vials; (c) 79,589 vials; (d) 50,948 vials; (e) 344,890 vials were distributed. Reason: Unapproved overages of preservatives in diluent. CLASS III -- CONRAY 400, IOTHALAMATE SODIUM INJECTION 66.8%, in 25 ml vials, an Rx iodinated contrast imaging media. Recall number: D-304-0. Lot numbers: D030A, D068A, D115A. Manufacturer: Mallinckrodt Inc., Raleigh, North Carolina. Recalled by: Manufacturer, by letter May 31, 1990. Firm-initiated recall ongoing. Distribution: Nationwide, Brazil. 439 cases were distributed. Reason: Labels incorrectly stated 688 mg/ml organically bound iodine, instead of 400 mg/ml organically bound iodine. CLASS III -- DERMATOPICS PRESCRIPTION FORMULA BENZOYL PEROXIDE 10% GEL Packaged in 3 ounce plastic tablets, an OTC topical anti-acne medication. Recall number: D-297-0. Lot #F-094 EXP 11/91. Manufacturer: Topiderm Inc., also known as Phamagen Inc., Bohemia, New York. Recalled by: Manufacturer, by telephone on or about April 24, 1990. Firm-initiated field correction ongoing. Distribution: Florida, New York, Massachusetts. 4,623 tubes were distributed; firm estimated 24 mislabeled units remained on market at time of recall initiation. Reason: Main label panel correctly declares 10 percent strength while ingredient statement declares 5 percent. CLASS III -- (a) LIDOCAINE HCl 1% AND EPINEPHRINE 1:100,000 INJECTION, USP; (b) LIDOCAINE HCl 2% AND EPINEPHRINE 1:100,000 INJECTION, USP Products are Rx small volume parenterals in 30 ml clear glass vials indicated for production of local anesthesia by nerve block or infiltration injection. Recall number: D-314/315-0. Code: (a) (a) 128053, 049047, 099029, 128028, 049072, 099047, 019031, 059049, 099006, 019077, 059015, 099083, 091056, 069012, 109015, 019079, 069354, 109037, 029049, 069059, 109102, 029051, 069351, 109056, 029065, 069055, 119026, 029080, 069028, 119008, 029061, 069076, 129003, 029078, 079052, 010005, 039010, 079032, 010039, 039384, 089048, 010054, 039015, 099026, 010041, 109075, 022043; (b) 029014, 079008, 029063, 089056, 039012, 019017, 109077, 039380, 129001, 049091, 010022, 059090, 020019, 069078. Manufacturer: Elkins-Sinn Inc., Cherry Hill, New Jersey. Recalled by: Manufacturer, by telephone May 2 and 21, 1990 followed by letter June 18, 1990. Firm-initiated recall ongoing. Distribution: Virginia, Texas, Illinois, California. Approximately 61 lots in shelf packs of 25/30 ml vials each were distributed. Reason: Subpotency of epinephrine ingredient. CLASS III -- LILLY BRAND SULFADIAZINE TABLETS, USP 0.5 gm, an Rx sulfonamide drug used as a bacteriostatic agent in bottles of 100. Recall number: D-295-0. Lot numbers: 9NW33A EXP 9/1/90; Lot numbers: OLZ24A, EXP: 2/1/91; Lot numbers: OMR92A, EXP: 6/1/91; Lot numbers: 1AX70A, EXP: 4/1/92; Lot numbers: 1CY80A, EXP: 7/1/92; Lot numbers: 1EJ73A, EXP: 11/1/92; Lot numbers: 1EX46A, EXP: 2/1/93; Lot numbers: 2PG16A, EXP: 9/1/93; Lot numbers: 2RL72A, EXP: 3/1/94; Lot numbers: 3AS15A, EXP: 4/1/94; Lot numbers: 3CH71A, EXP: 6/1/94. Manufacturer: Eli Lilly & Company, Indianapolis, Indiana. Recalled by: Manufacturer, by letter May 16, 1990. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico, Barbados. 61,560 bottles were distributed. Reason: Product may not meet dissolution specifications through expiration date. CLASS III -- SELENIUM SULFIDE LOTION USP 2.5%, in 4 fluid ounce bottles, an Rx antiseborheic and antifungal preparation for dermatological use, under the Major, United Research Labs, Inc., Rugby and Barre labels. Recall number: D-305-0. Lot numbers and EXP dates: 72262 6/90, 72454 10/90, 82014 1/91, 82015 2/91, 82258 5/91, 82473 10/91, 82670 1/92, 92174 4/92, 92420 7/92, 92445 8/92, 92667 10/92, 92668 10/92, 92669 9/92, 92873 1/93. Manufacturer: Barre-National Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter May 9, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 1,140,312 bottles were distributed; firm estimates 76,417 bottles remain on market. Reason: Incorrect expiration date of 36 months was used instead of 24 months. CLASS III -- THEOPHYLLINE ELIXIR 80 mg/15 ml, in 1 pint and 1 gallon bottles, an Rx bronchodilator, under the Barre, Schein, Bioline, Moore, Major, Haber and Goldline labels. Recall number: D-302-0. Lot numbers and EXP dates: 82671 01/93, 92063 01/93, 92179 06/93, 92427 07/93, 92443 07/93, 92581 09/93, 92646 10/93, 92647 10/93, 92862 12/93, 92863 01/94. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter May 9, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 228,548 bottles were distributed; firm estimates 12,340 bottles remain on market. Reason: Incorrect expiration date of 48 months was used instead of 24 months. CLASS III -- TRILAFON CONCENTRATE (PERPHENAZINE USP) 16 mg/5 cc, in 4 ounce bottles, an Rx drug indicated for use in the management of the manifestations of psychotic disorders and for control of nausea and vomiting in adults. Recall number: D-301-0. Lot numbers: 6-ADT-5 (10/91), 7-ADT-1 (2/92), 7-ADT-2 (4/92), 7-ADT-3 (7/92), 7-ADT-4 (10/92), 7-ADT-5 (12/92), 8-ADT-1 (3/93), 8-ADT-2 (6/93), 8-ADT-3 (9/93), 8-ADT-4 (11/93), 9-ADT-1 (2/94), 9-ADT-2 (5/94), 9-ADT-3 (8/94), 9-ADT-4 (11/94), 0-ADT-1 (1/95). Manufacturer: Schering Laboratories, Division of Schering-Plough Inc., Union, New Jersey. Recalled by: Manufacturer, by letter mailed April 6, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 243,000 bottles were distributed. Reason: Stability testing indicates potency not assured through expiration date.