FDAFDA · Food and drugs·Recall number D-0650-2020
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
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, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.