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October 26, 1999

Marsam Pharmaceuticals, Inc. Recalls Sterile Cefazolin Sodium

Cherry Hill, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Marsam Pharmaceuticals is recalling certain lots of Sterile Cefazolin Sodium for failure to meet pH specifications.

The Cefazolin Sodium is a Rx semi-synthetic cephalosporin for IM or IV administration and is indicated in the treatment of serious infections.  The recalled drugs contained 1 gram in 10 mL vials and 10 grams in 100 ml vials.

This ongoing recall was initiated by the company on May 3, 1999 by letter.  This is the first notice the FDA has issued to the general public of the recall.

Over 6,000 Trays of this medicine have been distributed.  The 10 mL vials were distributed nationwide while the 100 mL vials were sent only to Massachusetts.  These products can be identified by the following codes.

10 mL Vials
Lot # 9706054 (Control #7F91884) EXP 06/99, NDC 0209-0900-24;

100mL vials
Lot #9705035 (Control # 7E91833) EXP 05/99, NDC 0209-1100-52.

(Note: the Control Number identifies All products on the label. The firm's lot number does not appear on the label).

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

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