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SafetyAlerts
May 24, 2000

Abbott Laboratories Recall Lorazepam Injection

Abbott Park, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Abbott Laboratories, Hospital Products Division, is conducting a recall of Lorazepam Injection because of mislabeling - Incorrect drug concentration declared (2 mg lorazepam). (Drug title correctly cites 4 mg/ml).

The Lorazepam Injection is a prescription or preanesthetic medication of adult patients to produce sedation, relief of anxiety and a decreased ability to recall events related to the day of surgery. The recalled products are 4 mg/ml, in 10 mL multiple dose vial (NDC #0074-1539-10) and 1 mL Carpujec(r)/needle prefilled
syringe (NDC #0074-1539-11) and bear the Lot Numbers of 44-635-3B, 49-650-3B and 46-315-3A

FDA stated in its report that 55,750 1-mL syringes and 2,392 10-mL vials were distributed nationwide.  The firm estimated that less than 5,000 -1-mL syringes and 1,500 10-mL vials remained on the market at time of recall initiation.

This ongoing Class III recall was initiated by the company, by letter on by letter dated March 16, 2000. This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-345-0

Notice of this product warning was sent via email to SafeMail subscribers May 24, 2000.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.