November 2012 FDA Recall Vivitrol by Alkermes, Inc.
D-819-2013 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Alkermes, Inc. on November 6, 2012 for the product Vivitrol. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-819-2013

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.
Initiated
11-06-2012
Reported
07-31-2013
Quantity
3,325 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65092
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2013
Product Description About Product Description
Full technical description of the product.
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,

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

65757-300-01 Vivitrol
65757-301-01 Vivitrol