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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 8, 1998

PRODUCT
Ascorbic Acid Injection, USP, 500 mg/2mL, in amber glass ampules,Rx, intended for intramuscular, intravenous or subcutaneous administration, under the Schein label. NDC #0364-2361-42.Recall #D-189-8.

CODE
Lot numbers: 96J570 EXP 8/98 and 96L790 EXP 10/98.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on June 12, 1998. Firm-initiated recallongoing.

DISTRIBUTION
Nationwide.

QUANTITY
143,750 bottles of lot 96J570 and 139,975 bottles of lot 96L790were distributed.

REASON
Inconsistent physical appearance (color specification).

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.