FDA Drug recall D-248-2013
buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic…
- FDA Drug
- Class III
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class III recall of buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic… by Actavis South Atlantic, citing failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-248-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-03-22 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis South Atlantic |
| Distribution | US |
Product
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.
Reason
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Identifiers
| code_info | Lot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13;…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-248-2013%22
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