Drug recall D-1556-2014

Class II Terminated reported Sep 3, 2014

Product

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.

Lots and codes

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.

Recall details

Recalling firm
Alkermes, Inc., Waltham, MA
Quantity
4,364 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 4, 2014
Terminated
December 22, 2014

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