Drug recall: Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
FDA enforcement event 84550 is a drug recall by Asclemed USA Inc. dba Enovachem Pharmaceuticals of Torrance, CA, initiated 9 Dec 2019 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 9 Aug 2023. Initiation: voluntary: firm initiated. Asclemed USA Inc. dba Enovachem Pharmaceuticals has 2 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Asclemed USA Inc. dba Enovachem Pharmaceuticals, Torrance, CA.
Reason for recall
"Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results."
Distribution
"Product was distributed to 6 physician's offices within the state of California."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0650-2020 | Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36 | 8.52 gm | Class II | Terminated | 15 Jan 2020 |
| D-0651-2020 | Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37 | 42.12 gm | Class II | Terminated | 15 Jan 2020 |
| D-0652-2020 | Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38 | 56.4 gm | Class II | Terminated | 15 Jan 2020 |
Context
Other enforcement events for Asclemed USA Inc. dba Enovachem Pharmaceuticals
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Mar 2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enov (87548) | Drug | Class III | 1 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed to 6 physician's offices within the state of California."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Aug 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.