Why it was recalled
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Product description
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,
Lot numbers, UPCs & expiration codes
Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
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-819-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 6, 2012
- FDA report date
- Jul 31, 2013
- Quantity
- 3,325 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alkermes, Inc.
Original FDA data
Every field from FDA enforcement report D-819-2013, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 65092
- Address
- 852 Winter St
- Code information
- Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
- Postal code
- 02451-1420
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-819-2013
- Classification
- Class II
- Recalling firm
- Alkermes, Inc.
- Product quantity
- 3,325 vials
- Termination date
- Aug 28, 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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,
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 6, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2013