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SafetyAlerts
October 16, 2003

American Pharmaceutical Partners Has Recalled Haloperidol Injection

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

PRODUCT
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.

CODE
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.

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

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

VOLUME OF PRODUCT IN COMMERCE
2,256,625 vials.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
Selected Recent Recalls


Health Professional:

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During 2000 there were over
1050 products recalled in the United
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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.