Alkermes Inc recalls Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380…

Recall date

August 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1846-2019

FDA classification

Class II

Brand / firm

Alkermes Inc

Sold / distributed

Distributed Nationwide in the USA

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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