Drug recall
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
FDA recall event 84550 · Class II · Asclemed USA Inc. dba Enovachem Pharmaceuticals
Key facts
| Event ID | 84550 |
|---|---|
| Recall numbers | D-0650-2020, D-0651-2020, D-0652-2020 |
| Recalling firm | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
| Product type | Drugs |
| Products | Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36, Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37, Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. |
| Initiation date | Dec 9, 2019 |
| Report date | Jan 15, 2020 |
| Termination date | Aug 9, 2023 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 3001452204 |
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: