Drug 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
D-0119-2020
Product summary
- Firm
- Alkermes, Inc.
- Event
- Event 83878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,231 kits
- Official record key
drug-enforcement:D-0119-2020
Official wording
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.
Code information: Lot 2019-1002T, 2019-1003T, Exp 05/2021
Distribution pattern: Nationwide USA and Canada
Derived failure modes
-
Unknown
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.