FDA Drug recall D-819-2013
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, R…
- FDA Drug
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of 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, R… by Alkermes, citing lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-819-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-06 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Alkermes |
| Distribution | US |
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,
Reason
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Identifiers
| ndc | 65757-300-01 |
|---|---|
| ndc | 65757-302-02 |
| ndc | 65757-304-03 |
| ndc | 65757-301-01 |
| ndc | 65757-303-02 |
| ndc | 65757-305-03 |
| code_info | Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-819-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.