Drug recall
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per…
FDA recall event 94891 · Class II · Amerisource Health Services LLC
Key facts
| Event ID | 94891 |
|---|---|
| Recall numbers | D-0590-2024 |
| Recalling firm | Amerisource Health Services LLC |
| Product type | Drugs |
| Products | buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Dissolution Specifications; the product is dissolving faster than the specified limits. |
| Initiation date | Jun 24, 2024 |
| Report date | Jul 17, 2024 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3000209995 |
At a glance
- 1–9 Products in this recall
- 10–99 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: