buPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-002-2013
Terminated recall by McKesson Packaging Services, reported 2012-10-10, distributed nationwide. Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stab
| Recall number | D-002-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | McKesson Packaging Services, Concord, NC, United States |
| Recall initiated | 2012-03-29 |
| Classified | 2012-10-01 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 674 cartons |
| Reason classes | specification failure |
| NDC | 63739-0450-10 |
| Lot numbers | 0074584, 0075375, 08/12 |
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 for recall
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-002-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.