Vivitrol recall: Sterility Concern
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,
Why was Vivitrol recalled?
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
- Product
- 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,
- Recalling firm
- Alkermes, Inc.
- Quantity
- 3,325 vials
- Distribution
- Nationwide
- Recall date
- July 31, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)