FDAFDA · Food and drugs·Recall number D-819-2013
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,
Published July 31, 2013 · Recall initiated: November 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VIVITROL
- Manufacturer
- Alkermes, Inc.
- Distributor
- Nationwide
- Lot
- Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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