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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 and Vecuronium Bromide For Injection

Phoenix, AZ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Steris Laboratories, Inc. is recalling Chorionic Gonadotropin and Vecuronium Bromide For Injection because the diluent sold with product was found to contain "white fibers".

PRODUCT
a) Chorionic Gonadotropin For Injection, USP (Human), in 10 mL multiple dose vial, packaged with diluent, 5,000 USP Units, under the Eveready label;
b) Chorionic Gonadotropin For Injection, USP (Human), in 10 mL multiple dose vial, packaged with diluent, 10,000 USP units, under the following labels: Steris, Serono, Zenith,
c) Vecuronium Bromide For Injection, USP, 10 mg, in 10 mL vial, packaged with diluent, under the VHA Plus and Marsam labels. Recall D-201/203-9.

CODE
Lot Numbers NDC Numbers
a) 97L910 57548-125-10
b) 97K710 0402-0126-10 97J410 44087-8010-3 97J510 0182-1165-63
c) 97K950 0209-9141-96 97L550 0209-9141-26.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letters dated February 14 and 23, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
a) 996 vials;
b) 23,351 vials;
c) 77,099 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.