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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 13, 1999

PRODUCT
Various Rx drugs: a) Sus-phrine Injectable Suspension (Epinephrine), 1.5 mg/ampul (1:200), 0.3 mL Sterile ampuls, a sterile, on-pyrogenic suspension for subcutaneous injection, under the Forest label. NDC #0456-0664-39; b) Meperidine Hydrochloride Injection, USP, 50 mg/mL, 30 mL Sterile Multiple Dose vial, a narcotic analgesic, under the Steris (NDC #0402-0947-30), Schein (NDC0364-3026-560 labels; c) Hydromorphone Hydrochloride Injection, USP, 50mg/5mL, 5 mL ampul, a narcotic analgesic, under the Marsam Pharmaceutical label. NDC #0209-4237-12. Recall #D-068/070-9.

CODE
Lot numbers: a) 97M040; b) 96M510; c) 96M830 and 97A680.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on November 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
a) Missouri; b) Arizona, California, Colorado, Connecticut, Florida, Iowa, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Texas, Virginia, Wisconsin, West Virginia; c) Nationwide.

QUANTITY
a) 87,610 ampuls; b) 2,648 ampuls; c) 16,750 ampuls were distributed.

REASON
Current Good Manufacturing Practice Deviations (Lack of or incomplete process validation).

 

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.