FDAFDA · Food and drugs·Recall number D-1556-2014
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.
Published September 3, 2014 · Recall initiated: March 4, 2014
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
Customer complaints for failure to deliver the dose.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VIVITROL
- Manufacturer
- Alkermes, Inc.
- Distributor
- Nationwide
- Lot
- Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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