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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 5, 1999

Steris Laboratories, Inc. Recalls Chorionic Gonadotropin for Injection

Phoenix, AZ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Steris Laboratories, Inc. is recalling Chorionic Gonadotropin for Injection, USP (human), Lyophilized, 10,000 USP Units, in 10 mL sterile multiple dose vials, because the product was compounded at lower potency than required by NDA and/or product was found to have atypical rejection level for visual particulates.

Lamprene(r) Soft Gelatin CapsulesChorionic Gonadotropin for Injection is a prescription sold under the labels of Steris, Serono, and Schein. (NDC #0402-0126-10, 44087-8010-3, 0364-6706-54)

Recall #D-200-9.

CODE
Lot numbers: 97H730 and 98B550.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter dated February 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Puerto Rico, Haiti, Trinidad.

QUANTITY
33,675 vials were distributed.

 

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.