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Recall Observatory FDA recall evidence

Drug product

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38

D-0652-2020

December 09, 2019

Class II

Product summary

Firm
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Event
Event 84550
Status
Terminated
Classification
Class II
Quantity
56.4 gm
Official record key
drug-enforcement:D-0652-2020

Official wording

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

Code information: Lot Code/Exp. Date: 11191804, 12281802, 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 04091903, 04221907, 05211902, 06071902, 06241903, 07111903, 07301902, 08271902, 09061904, 09161902, EXP 12/31/2020; 09161901, 10091905, 10221902, 10311901, EXP 5/31/2021; 11211902, 10311902, EXP 8/31/2021

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