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,
Reported: July 31, 2013 Initiated: November 6, 2012 #D-819-2013
Product Description
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,
Reason for Recall
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Details
- Recalling Firm
- Alkermes, Inc.
- Units Affected
- 3,325 vials
- Distribution
- Nationwide
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by Alkermes, Inc.. Units affected: 3,325 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2013. Severity: Moderate. Recall number: D-819-2013.
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