VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,

FDA recall notice · announced July 31, 2013 · Alkermes

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,

Reason for recall

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

Notes

Distribution: Nationwide
Lot/code information: Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
Quantity: 3,325 vials
Status: Terminated
Products in this recall event:
- VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, (D-819-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.