Status
Terminated
Drug Enforcement D-819-2013
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Classification
Class II
Report Date
July 31, 2013
Termination Date
August 28, 2013
Product Information
- 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,
- Product quantity
- 3,325 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Alkermes, Inc.
- Address
-
852 Winter St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-819-2013
- Event ID
- 65092
- Recall initiation date
- November 6, 2012
- Center classification date
- July 24, 2013
- Code info
- Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
- More code info
- —