FDAFDA · Food and drugs·Recall number D-0119-2020
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
Published October 9, 2019 · Recall initiated: September 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VIVITROL
- Manufacturer
- Alkermes, Inc.
- Distributor
- Nationwide USA and Canada
- Lot
- Lot 2019-1002T, 2019-1003T, Exp 05/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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