Home / Recalls / Alkermes, Inc. / D-819-2013

D-819-2013 Class II Terminated

Recalled by Alkermes, Inc. — Waltham, MA

Recall Details

Product Type
Drugs
Report Date
July 31, 2013
Initiation Date
November 6, 2012
Termination Date
August 28, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,325 vials

Product Description

VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,

Reason for Recall

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

Distribution Pattern

Nationwide

Code Information

Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13

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-1556-2014 Class II — VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial N (March 4, 2014)