FDA-Drug2020-01-15Class II

Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36

Asclemed USA Inc. dba Enovachem Pharmaceuticals
Hazard

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

Sold states
Product was distributed to 6 physician's offices within the state of California.
Affected count
8.52 gm
Manufactured in
379 Van Ness Ave Ste 1403, N/A, Torrance, CA, United States
Products
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0650-2020

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