FDA-Drug2020-01-15Class II
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
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
56.4 gm
Manufactured in
379 Van Ness Ave Ste 1403, N/A, Torrance, CA, United States
Products
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2020Don't want to check this manually?
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