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Recall Observatory FDA recall evidence

Drug product

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

D-0650-2020

December 09, 2019

Class II

Product summary

Firm
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Event
Event 84550
Status
Terminated
Classification
Class II
Quantity
8.52 gm
Official record key
drug-enforcement:D-0650-2020

Official wording

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

Code information: Lot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification