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Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #7...

FDA Recall #D-0651-2020 — Class II — December 9, 2019

Recall #D-0651-2020 Date: December 9, 2019 Classification: Class II Status: Terminated

Product Description

Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37

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

42.12 gm

Distribution

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

Code Information

Lot Code/Exp. Date: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 10111903, EXP 5/31/2021; 11211904, 10161901, EXP 8/31/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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