Recalls / Class II
Class IID-1556-2014
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.
- Brand name
- Vivitrol
- Generic name
- Naltrexone
- NDCs
- 65757-300, 65757-301
- FDA application
- NDA021897
- Affected 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.
Why it was recalled
Customer complaints for failure to deliver the dose.
Recalling firm
- Firm
- Alkermes, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 852 Winter St, N/A, Waltham, Massachusetts 02451-1420
Distribution
- Quantity
- 4,364 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-03-04
- FDA classified
- 2014-08-22
- Posted by FDA
- 2014-09-03
- Terminated
- 2014-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1556-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.