Drug product
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
D-0650-2020
Product summary
- Event
- Event 84550
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8.52 gm
- Official record key
drug-enforcement:D-0650-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Code information: Lot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020
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