Home / Recalls / Alkermes, Inc. / D-0119-2020

D-0119-2020 Class II Terminated

Recalled by Alkermes, Inc. — Waltham, MA

Recall Details

Product Type
Drugs
Report Date
October 9, 2019
Initiation Date
September 26, 2019
Termination Date
February 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,231 kits

Product Description

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

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 Pattern

Nationwide USA and Canada

Code Information

Lot 2019-1002T, 2019-1003T, Exp 05/2021

Other recalls by Alkermes, Inc.

  • D-1846-2019 Class II — Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Ea (August 8, 2019)
  • D-1556-2014 Class II — VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial N (March 4, 2014)
  • D-819-2013 Class II — VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial (November 6, 2012)