FDA Drug recall D-002-2013
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation,…
- FDA Drug
- Class III
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class III recall of buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation,… by Mckesson Packaging Services, citing failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-002-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-03-29 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mckesson Packaging Services |
| Distribution | US |
Product
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.
Reason
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Identifiers
| code_info | Lot #: 0075375, 0074584, Exp 08/12 |
|---|
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-002-2013%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.