Drug recall
buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only…
FDA recall event 63127 · Class III · McKesson Packaging Services
Key facts
| Event ID | 63127 |
|---|---|
| Recall numbers | D-001-2013, D-002-2013 |
| Recalling firm | McKesson Packaging Services |
| Product type | Drugs |
| Products | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 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…, 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. |
| Initiation date | Mar 29, 2012 |
| Report date | Oct 10, 2012 |
| Termination date | Apr 11, 2013 |
| City | Concord |
| State | NC |
| Country | United States |
| FEI number | 3000206187 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: