FDA Drug recall D-0119-2020
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial
- FDA Drug
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial by Alkermes, citing labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0119-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-26 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alkermes |
| Distribution | US |
Product
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01
Reason
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
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 | Lot 2019-1002T, 2019-1003T, Exp 05/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0119-2020%22
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