Why it was recalled
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Product description
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Lot numbers, UPCs & expiration codes
Lots: 524099M, 524100A, 521687A
Where it was sold
Nationwide and Puerto Rico
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-1043-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 15, 2013
- FDA report date
- Feb 5, 2014
- Quantity
- 139,944 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-1043-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66961
- Address
- 400 Interpace Pkwy
- Code information
- Lots: 524099M, 524100A, 521687A
- Postal code
- 07054-1120
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1043-2014
- Classification
- Class III
- Recalling firm
- Actavis Inc
- Product quantity
- 139,944 bottles
- Termination date
- Jun 16, 2015
- Reason for recall
- Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 29, 2014