Drug recall
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b)…
FDA recall event 78364 · Class II · Teva Pharmaceuticals USA
Key facts
| Event ID | 78364 |
|---|---|
| Recall numbers | D-0069-2018 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results. |
| Initiation date | Oct 25, 2017 |
| Report date | Nov 8, 2017 |
| Termination date | May 2, 2018 |
| City | North Wales |
| State | PA |
| Country | United States |
| FEI number | 3003092769 |
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: