Status
Terminated
Drug Enforcement D-248-2013
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Classification
Class III
Report Date
April 24, 2013
Termination Date
May 9, 2014
Product Information
- 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.
- Product quantity
- 555,672 bottles
- Reason for recall
- Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Actavis South Atlantic LLC
- Address
-
13800 Nw 2nd St Ste 190, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-248-2013
- Event ID
- 64846
- Recall initiation date
- March 22, 2013
- Center classification date
- April 12, 2013
- Code info
- 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
- More code info
- —