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SafetyAlerts
May 16, 2002

Abbott Laboratories Has Recalled Mivacron and Nimbex Injection

(SafetyAlerts) - The Food and Drug Administration (FDA) said that Abbott Laboratories Has Recalled Mivacron and Nimbex Injection.

PRODUCT
a) Mivacron Injection (mivacurium chloride), Equivalent to 20 mg/10 mL (2 mg/mL) mivacurium, 10 mL Single-dose Fliptop Vial, Rx only. Recall # D-253-2;
b) Nimbex Injection (cisatracurium besylate), Equivalent to 10mg/5mL (2 mg/mL) cisatracurium, 5 mL Single-dose Vial, Rx only. Recall # D-254-2;
c) Nimbex Injection (cisatracurium besylate), 20 mg/10 mL(2 mg/mL), 10 mL Multiple-dose Vial, Rx only.
Recall # D-255-2.

CODE
a) NDC #0074-4365-10, lot 0H2493, exp. 05/02;
b) NDC #0074-4378-05, lot 0E2030, exp. 12/01
c) NDC #0074-4380-10, lot 0E2033, exp. 01/02.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., Hospital Products Division, Abbott Park, IL, by letters dated December 7, 2001.
Manufacturer: DSM Catalytica Pharmaceuticals, Inc., Greenville, NC. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE
a) 107,360 vials;
b) 52,610 - 5 ml vials;
c) 102,690 - 10 ml vials.

DISTRIBUTION
Nationwide.

 
Selected Recent Recalls


Health Professional:

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

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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.