Laboratories, Inc. Recalls Chorionic Gonadotropin for Injection
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 5, 1999
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)
Lot numbers: 97H730 and 98B550.
Steris Laboratories, Inc., Phoenix, Arizona.
Manufacturer, by letter dated February 15, 1999. Firm-initiated recall ongoing.
Nationwide, Puerto Rico, Haiti, Trinidad.
33,675 vials were distributed.