post #1 of 1
10/5/03 at 2:21pm
Thread Starter 
(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Zemuron Injection, (rocuronium bromide) 10 mg/mL, For IV use only, professional sample of 6X5mL vials, 5mL and 10mL multiple dose vials. Recall # D-310-3.

CODE
Packaged Lot Numbers: 2442902450, exp. July 2004; 2453002450, exp. July 2004; 2463102450, exp. July 2004; 0583102450, exp. July 2004; 0593302450, exp. July 2004; 2483702450, exp. August 2004; 2493702450, exp. August 2004; 0023702450, exp. August 2004; 2513802450, exp. August 2004; 2623802450, exp. August 2004; 0634002450, exp. August 2004; 0644002450, exp. August 2004; Packaged Lot Numbers: 1483402450, exp. August 2004; 1493502450 exp. August 2004; 1503602450, exp. August 2004. The packaged lot number has an additional three digit packaging before the manufactured lot number.

RECALLING FIRM/MANUFACTURER
Organon, Inc., West Orange, NJ, by letters on July 1, 2003. FDA initiated recall is ongoing.

REASON
Vials may contain metal particles.

VOLUME OF PRODUCT IN COMMERCE
1,582,420 vials.

DISTRIBUTION
Nationwide and Canada.
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