Drug recall D-819-2013
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.
Lots and codes
Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
Recall details
- Recalling firm
- Alkermes, Inc., Waltham, MA
- Quantity
- 3,325 vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 6, 2012
- Terminated
- August 28, 2013
Related products
- Vivitrol – drug information
- NDC 65757-301 Vivitrol · · Alkermes, Inc.
- NDC 65757-300 Vivitrol · · Alkermes, Inc.