Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Recalled January 15, 2020 · FDA recall D-0651-2020 · Asclemed USA Inc.
Hazard
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. · FDA Class II
Units
42.12 gm
Sold at
Product was distributed to 6 physician's offices within the state of California.
Description
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Product
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Manufacturer(s)
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →