Why it was recalled
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Product description
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
Lot numbers, UPCs & expiration codes
Lot # 1826E131, Exp 04/2015
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-1153-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 10, 2014
- FDA report date
- Mar 19, 2014
- Quantity
- 9447 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-1153-2014, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67519
- Address
- 200 Elmora Ave
- Code information
- Lot # 1826E131, Exp 04/2015
- Postal code
- 07202-1106
- Report date
- Mar 19, 2014
- Product type
- Drugs
- Recall number
- D-1153-2014
- Classification
- Class II
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 9447 Bottles
- Termination date
- Aug 25, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 10, 2014