Recalls / Class II
Class IID-0652-2020
Product
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
- Affected lot / code info
- Lot Code/Exp. Date: 11191804, 12281802, 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 04091903, 04221907, 05211902, 06071902, 06241903, 07111903, 07301902, 08271902, 09061904, 09161902, EXP 12/31/2020; 09161901, 10091905, 10221902, 10311901, EXP 5/31/2021; 11211902, 10311902, 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
- 56.4 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-0652-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.