FDAFDA · Food and drugs·Recall number D-0652-2020
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Published January 15, 2020 · Recall initiated: December 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Distributor
- Product was distributed to 6 physician's offices within the state of California.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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