Reported Sep 3, 2014 · Terminated
VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured…
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); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.
- Lot codes and dates
- Batch Number
412-3732AAexpiration date 07/2016 (NDC# 65757-302-02
- Kit Pacaging Lot Number
2013-021expiration date 07/2016 (NDC# 65757-300-01
- Batch Number
- Amount recalled
- 4,364 vials
Where it was sold
- Nationwide
Why it was recalled
Customer complaints for failure to deliver the dose.
This product could cause temporary or reversible health problems — stop using it.
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