Recalls / Class II
Class IID-0119-2020
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
- Brand name
- Vivitrol
- Generic name
- Naltrexone
- NDCs
- 65757-300, 65757-301
- FDA application
- NDA021897
- Affected lot / code info
- Lot 2019-1002T, 2019-1003T, Exp 05/2021
Why it was recalled
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.
Recalling firm
- Firm
- Alkermes, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 852 Winter St, N/A, Waltham, Massachusetts 02451-1420
Distribution
- Quantity
- 16,231 kits
- Distribution pattern
- Nationwide USA and Canada
Timeline
- Recall initiated
- 2019-09-26
- FDA classified
- 2019-10-02
- Posted by FDA
- 2019-10-09
- Terminated
- 2021-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0119-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.