October 20, 1999Marsam 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
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.