Reported Oct 9, 2019 · Terminated
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains
Alkermes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alkermes, Inc. · 852 Winter St · Waltham, MA · 02451-1420
Is this the product you have?
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains
6 of 6 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
Lot 2019-1002T2019-1003TExp 05/2021
- Amount recalled
- 16,231 kits
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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