Why it was recalled
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Product description
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Lot numbers, UPCs & expiration codes
Lot #: CG2D18A, Exp 06/14
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-855-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 31, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 15,132 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-855-2013, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65881
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: CG2D18A, Exp 06/14
- Postal code
- 07054-1120
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-855-2013
- Classification
- Class III
- Recalling firm
- Actavis Inc
- Product quantity
- 15,132 bottles
- Termination date
- May 9, 2014
- Reason for recall
- Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 31, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2013