October 20, 1999Marsam Pharmaceuticals,
Inc. Cefazolin Sodium, USP, Rx and Ampicillin Sodium, USP, Rx Recalled
Cherry Hill, NJ (SafetyAlerts) - The U.S. Food and Drug
Administration (FDA) issued notice today that Marsam Pharmaceuticals, Inc. has an ongoing
recall of certain lots of their Cefazolin Sodium, USP, Rx and Ampicillin Sodium, USP, Rx
because the product was found to have potency problems. Testing indicated that these
drugs did not maintain proper potency levels and were either super-potent or sub-potent.
The recall was initiated by the
company on May 17, 1999 by letter. This is the first notice the FDA has issued to
the general public of the recall.
The drugs recalled were:
a) Cefazolin Sodium, USP, Rx,
Sterile,10 grams, 100 mL vial;
b) Cefazolin Sodium, USP, Rx, Sterile,1 gram, 100 mL vial,
c) Ampicillin Sodium, USP, Rx, Sterile, in 10g, 100 mL vial.
The 10 gram Cefazolin (a) affected by
this recall bear the codes of Lot# 9901006 (Control #9M02727) EXP 12/2000 - NDC
The 1 gram Cefazolin (b) bear the
codes Lot # 9801005 (Control #8M92223) EXP 12/99 - NDC 0209-1000-42.
The Ampicillin (c) Lot# 9710002
(Control #7J02055) EXP 09/2000, NDC 0209-0450-52.
All products are identified on the
label by the Control Number. The firm's lot number does not appear on the label.
Over 9000 trays of the affected
products were recalled and distributed nationwide.
Users with question may contact the
FDA at 1-800-INFO-FDA
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