Why it was recalled
Customer complaints for failure to deliver the dose.
Product description
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1556-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 4, 2014
- FDA report date
- Sep 3, 2014
- Quantity
- 4,364 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alkermes, Inc.
Original FDA data
Every field from FDA enforcement report D-1556-2014, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 67838
- Address
- 852 Winter St
- 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.
- Postal code
- 02451-1420
- Report date
- Sep 3, 2014
- Product type
- Drugs
- Recall number
- D-1556-2014
- Classification
- Class II
- Recalling firm
- Alkermes, Inc.
- Product quantity
- 4,364 vials
- Termination date
- Dec 22, 2014
- Reason for recall
- Customer complaints for failure to deliver the dose.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 4, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2014