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October 20, 1999

Marsam 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 0209-1100-52.

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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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.