Why it was recalled
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Product description
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
Lot numbers, UPCs & expiration codes
Lot #: 57617531, Exp 03/14
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-1091-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 4, 2014
- FDA report date
- Mar 12, 2014
- Quantity
- 5,148 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-1091-2014, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67518
- Address
- 200 Elmora Ave
- Code information
- Lot #: 57617531, Exp 03/14
- Postal code
- 07202-1106
- Report date
- Mar 12, 2014
- Product type
- Drugs
- Recall number
- D-1091-2014
- Classification
- Class II
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 5,148 bottles
- Termination date
- Jan 22, 2015
- Reason for recall
- Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 4, 2014
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2014