Why it was recalled
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Product description
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
Lot numbers, UPCs & expiration codes
Lot # 59380831, Exp. May 2014
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-018-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2013
- FDA report date
- Dec 4, 2013
- Quantity
- 756 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-018-2014, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66528
- Address
- 200 Elmora Ave
- Code information
- Lot # 59380831, Exp. May 2014
- Postal code
- 07202-1106
- Report date
- Dec 4, 2013
- Product type
- Drugs
- Recall number
- D-018-2014
- Classification
- Class II
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 756 bottles
- Termination date
- Nov 3, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 9, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2013