Drug product
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
D-0651-2020
Product summary
- Event
- Event 84550
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42.12 gm
- Official record key
drug-enforcement:D-0651-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
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
Distribution pattern: Product was distributed to 6 physician's offices within the state of California.
Derived failure modes
-
Potency or specification failure
Out of Specification