Class II
Terminated
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
This recall has been terminated (originally issued October 9, 2019).
- Company
- Alkermes, Inc.
- Recall Initiated
- September 26, 2019
- Posted
- October 9, 2019
- Recall Number
- D-0119-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,231 kits
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide USA and Canada
Lot / Code Info
Lot 2019-1002T, 2019-1003T, Exp 05/2021
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