Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Reported: January 15, 2020 Initiated: December 9, 2019 #D-0652-2020
Product Description
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Reason for Recall
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Details
- Recalling Firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Units Affected
- 56.4 gm
- Distribution
- Product was distributed to 6 physician's offices within the state of California.
- Location
- Torrance, CA
Frequently Asked Questions
What product was recalled? ▼
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38. Recalled by Asclemed USA Inc. dba Enovachem Pharmaceuticals. Units affected: 56.4 gm.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2020. Severity: Moderate. Recall number: D-0652-2020.
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