FDADecember 9, 2019drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

asclemed usa inc dba enovachem pharmaceuticalsasclemedasclemed usa

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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