Recalls / Class II
Class IID-0651-2020
Product
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Recalling firm
- Firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 379 Van Ness Ave Ste 1403, N/A, Torrance, California 90501-7211
Distribution
- Quantity
- 42.12 gm
- Distribution pattern
- Product was distributed to 6 physician's offices within the state of California.
Timeline
- Recall initiated
- 2019-12-09
- FDA classified
- 2020-01-08
- Posted by FDA
- 2020-01-15
- Terminated
- 2023-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0651-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.