Reported Jul 31, 2013 · Terminated
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit…
Alkermes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alkermes, Inc. · 852 Winter St · Waltham, MA · 02451-1420
Is this the product you have?
- 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,
- Lot codes and dates
Individual vial lot 402-3683AAEXP 10/13kit vial lot 2011-003EXP 08/13
- Amount recalled
- 3,325 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
This product could cause temporary or reversible health problems — stop using it.
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