FDA Drug recall D-0651-2020
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA
- FDA Drug
- Class II
- terminated
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA by Asclemed Usa, citing failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0651-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-09 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Asclemed Usa |
| Distribution | CA |
Product
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Reason
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Identifiers
| code_info | Lot Code/Exp. Date: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 1…Lot Code/Exp. Date: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 10111903, EXP 5/31/2021; 11211904, 10161901, EXP 8/31/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0651-2020%22
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