Why it was recalled
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
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.
Lot numbers, UPCs & expiration codes
Lot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13
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-248-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 22, 2013
- FDA report date
- Apr 24, 2013
- Quantity
- 555,672 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis South Atlantic LLC
Original FDA data
Every field from FDA enforcement report D-248-2013, exactly as published.
Show all FDA fields
- City
- Sunrise
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64846
- Address
- 13800 Nw 2nd St Ste 190
- Code information
- Lot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13
- Postal code
- 33325-6243
- Report date
- Apr 24, 2013
- Product type
- Drugs
- Recall number
- D-248-2013
- Classification
- Class III
- Recalling firm
- Actavis South Atlantic LLC
- Product quantity
- 555,672 bottles
- Termination date
- May 9, 2014
- Reason for recall
- Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2013