Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #7...
FDA Recall #D-0650-2020 — Class II — December 9, 2019
Product Description
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
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
8.52 gm
Distribution
Product was distributed to 6 physician's offices within the state of California.
Code Information
Lot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated