FDA Drug recall D-892-2013
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled t…
- FDA Drug
- Class III
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class III recall of buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled t… by American Health Packaging, citing failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-892-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-04 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | American Health Packaging |
| Distribution | US |
Product
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Reason
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Identifiers
| code_info | The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011. |
|---|
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-892-2013%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.