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November 30, 1999

Steris Laboratories Estrone Injectable Suspension and Gentamicin Sulfate Injection Recalled

Phoenix, AZ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Steris Laboratories is recalling the following products:
a) Estrone Injectable Suspension, USP, 5 mg/mL, in 10 ml multiple dose vials, Rx steriodal estrogen intended for intramuscular injection sold under NDC 0677-0274-21 from United Research Laboratories and NDC 57699-041-10 from A&G Pharmaceuticals.
b) Gentamicin Sulfate Injection, 40 mg/mL, 20 mL vial, Rx sterile aqueous solution for parenteral injection, under NDC 0402-0559-20 from Steris Laboratories, NDC 0182-1424-65 from Goldline Laboratories and NDC 0536-4690-73 from Rugby Laboratories.

These products have been recalled because of lack of annual stability data.

This Class III recall was initiated by the company, April 23, 1999 by letter.  This is the first notice the FDA has issued to the general public of the recall.  The FDA considers this recall complete.

Over 30,000 vials of  Estrone Injectable Suspension were distributed in New Jersey and Indiana and bear the lot number and expiration date of 98B250 EXP 2/01. Over 35,000 vials of Gentamicin Sulfate Injection were distributed nationwide and in Puerto Rico bearing 98B760 EXP 2/01, and 98D940.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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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.