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October 20, 1999

Marsam Pharmaceuticals, Inc.   Lorazepam Injection, USP Recalled

Cherry Hill, NJ (SafetyAlerts) - The U.S. Food and Drug Administration (FDA) issued notice today that  Marsam Pharmaceuticals has is continuing its recall of certain lots of their Lorazepam Injection, USP, 2 mg/mL, in 10 mL multiple dose vial, Rx, because the medication may be super-potent.

The recall was initiated by the company on June 8, 1999 by letter.  This is the first notice the FDA has issued to the general public of the recall.

Lorazepam Injection is indicated in adult patients for preanesthetic medication, producing sedation, relief of anxiety, and a decreased ability to recall events related to the day of surgery.

Over 10,000 cartons containing 1, mulitple dose vial were distributed nationwide.  The affected injection is from Lot# 9806034  EXP 05/2000NDC 0209-4581-20 and bears the Control #8E02499.   All products are identified on the label by the Control Number. The firm's lot number does not appear on the label.

Users with questions may contact the FDA at 1-800-INFO-FDA

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