Drug recall
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC…
FDA recall event 82158 · Class III · Amerigen Pharmaceuticals Inc.
Key facts
| Event ID | 82158 |
|---|---|
| Recall numbers | D-0516-2019 |
| Recalling firm | Amerigen Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed dissolution specifications |
| Initiation date | Feb 19, 2019 |
| Report date | Feb 27, 2019 |
| Termination date | Dec 17, 2019 |
| City | Lyndhurst |
| State | NJ |
| Country | United States |
| FEI number | 3008849302 |
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: