Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #7...
FDA Recall #D-0652-2020 — Class II — December 9, 2019
Product Description
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Reason for Recall
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Recalling Firm
Asclemed USA Inc. dba Enovachem Pharmaceuticals — Torrance, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
56.4 gm
Distribution
Product was distributed to 6 physician's offices within the state of California.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated