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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 12, 1998

PRODUCT
Morphine Sulfate Injection, USP, 15 mg/mL, in 20 mL multiple dose vials, Rx, a potent centrally active analgesic. NDC #0364-2366-55. Recall #D-213-8.

CODE
Lot #97B980.

MANUFACTURER
Steris Laboratories, Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on June 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
28,982 vials were distributed.

REASON
Manufacturing deviations (unapproved potency adjustment).

 

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.