D-0651-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2020
- Initiation Date
- December 9, 2019
- Termination Date
- August 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42.12 gm
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.
Distribution Pattern
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