Class II
Terminated
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,
This recall has been terminated (originally issued July 31, 2013).
- Company
- Alkermes, Inc.
- Recall Initiated
- November 6, 2012
- Posted
- July 31, 2013
- Recall Number
- D-819-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,325 vials
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
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