Class II
Terminated
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.
This recall has been terminated (originally issued September 3, 2014).
- Company
- Alkermes, Inc.
- Recall Initiated
- March 4, 2014
- Posted
- September 3, 2014
- Recall Number
- D-1556-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,364 vials
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Customer complaints for failure to deliver the dose.
Distribution
Nationwide
Lot / Code Info
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.
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