Recalls / Class II
Class IID-819-2013
Product
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,
- Brand name
- Vivitrol
- Generic name
- Naltrexone
- NDCs
- 65757-300, 65757-301
- FDA application
- NDA021897
- Affected lot / code info
- Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
Why it was recalled
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Recalling firm
- Firm
- Alkermes, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 852 Winter St, N/A, Waltham, Massachusetts 02451-1420
Distribution
- Quantity
- 3,325 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-11-06
- FDA classified
- 2013-07-24
- Posted by FDA
- 2013-07-31
- Terminated
- 2013-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-819-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.