(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
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
