FDAFDA · Food and drugs·Recall number D-0651-2020
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
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: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 10111903, EXP 5/31/2021; 11211904, 10161901, EXP 8/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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