Home / Recalls / Alkermes, Inc. / D-1556-2014

D-1556-2014 Class II Terminated

Recalled by Alkermes, Inc. — Waltham, MA

Recall Details

Product Type
Drugs
Report Date
September 3, 2014
Initiation Date
March 4, 2014
Termination Date
December 22, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,364 vials

Product Description

VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.

Reason for Recall

Customer complaints for failure to deliver the dose.

Distribution Pattern

Nationwide

Code Information

Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01.

Other recalls by Alkermes, Inc.

  • D-0119-2020 Class II — Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Ea (September 26, 2019)
  • D-1846-2019 Class II — Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Ea (August 8, 2019)
  • D-819-2013 Class II — VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial (November 6, 2012)