Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37

Recall date

December 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0651-2020

FDA classification

Class II

Brand / firm

Asclemed USA Inc. dba Enovachem Pharmaceuticals

Sold / distributed

Product was distributed to 6 physician's offices within the state of California.

Why it was recalled

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37