D-0650-2020 Class II Terminated
FDA drug recall D-0650-2020 was initiated by Asclemed USA Inc. dba Enovachem Pharmaceuticals on December 9, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. The recall status is terminated (terminated August 9, 2023). Affected quantity: 8.52 gm.
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
- 8.52 gm
Product Description
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
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, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020