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: July 11, 1990

Executive Summary

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS017748

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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