Bulk Estriol Recalled

Citing deviations from Current Good Manufacturing Practice regulations, API Solutions Inc is voluntarily recalling a single lot of estriol distributed in five states. The recall was included in the August 4, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects estriol USP 41 micronized, 25 grams (NDC 46144-300-01), from lot ETL181001 (Exp. 10/9/21). The product was manufactured by Wuhan Fortune Chemical Co., Ltd., China, and distributed by API Solutions, Daphne, AL, and Syntec Pharma Corp., NY, to customers in Alabama, Arizona, Colorado, Florida, and Virginia. 

API Solutions initiated the recall July 15, 2021. On July 28, 2021, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Estriol micronized is a bulk ingredient in a powder form. Estriol is a steroid, a weak estrogen, and a minor female sex hormone.