FDA Drug recall D-855-2013
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 2013-08-14
On 2013-08-14 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, citing failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-855-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-07-31 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| 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, UPC 3 67767-142-30 6.
Reason
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Identifiers
| upc | 367767142306 |
|---|---|
| code_info | Lot #: CG2D18A, Exp 06/14 |
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-855-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.