November 30, 1999Steris 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
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
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
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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