March 2014 FDA Recall Vivitrol by Alkermes, Inc.
D-1556-2014 - Customer complaints for failure to deliver the dose.
This Class II drug recall was voluntarily initiated by Alkermes, Inc. on March 4, 2014 for the product Vivitrol. The FDA reported the reason for recall as customer complaints for failure to deliver the dose.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1556-2014
Customer complaints for failure to deliver the dose.
03-04-2014
09-03-2014
4,364 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alkermes, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
12-22-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# 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.
