Drug 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.
D-1556-2014
Product summary
- Firm
- Alkermes, Inc.
- Event
- Event 67838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,364 vials
- Official record key
drug-enforcement:D-1556-2014
Official wording
Reason: Customer complaints for failure to deliver the dose.
Code information: 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.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Customer complaints for failure to deliver the dose.