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.
Reported: September 3, 2014 Initiated: March 4, 2014 #D-1556-2014
Product Description
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.
Reason for Recall
Customer complaints for failure to deliver the dose.
Details
- Recalling Firm
- Alkermes, Inc.
- Units Affected
- 4,364 vials
- Distribution
- Nationwide
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alkermes, Inc.. Units affected: 4,364 vials.
Why was this product recalled? ▼
Customer complaints for failure to deliver the dose.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 3, 2014. Severity: Moderate. Recall number: D-1556-2014.
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