FDA recall D-0651-2020

Asclemed USA Inc. dba Enovachem Pharmaceuticals · Class II · drug

Product

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

Product was distributed to 6 physician's offices within the state of California.

Key facts

Status
Terminated
Initiation date
2019-12-09
Report date
2020-01-15
Termination date
2023-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2020