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October 16, 2003

American Pharmaceutical Partners Has Recalled Haloperidol Injection

(SafetyAlerts) - The FDA has released the following information.

Haloperidol Injection, USP, 5 mg/mL, 1 mL vial, Rx Only, For Intramuscular Use, Sterile; American Pharmaceutical Partners, Inc., Schaumburg, IL: NDC 63323-474-01. The product was also sold under the AmeriNet Choice label: Haloperidol Injection, USP, 5mg/mL, 1 mL vial, Rx Only, For Intramuscular use, Sterile. Recall # D-328-3.

Lot Numbers: APP label: 111010, 111139, 111178, 111217, 120231, 120264, 120359, 120447,120691, 120725, 120838, 120917, 121028, 121049, 121468, 130281;
AmeriNet Choice label: 111217, 120628, 121468 and 130281.

American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters on August 13, 2003 and August 26, 2003. FDA initiated recall is ongoing.

Manufacturing Validation: The bulk solution mix time was not completed as per the validated process time.

2,256,625 vials.

Nationwide and Puerto Rico

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.