Spectrum Laboratory Products recalls Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G gl…

Recall date

December 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0628-2020

FDA classification

Class II

Brand / firm

Spectrum Laboratory Products

Sold / distributed

Nationwide in the USA and Canada

Why it was recalled

Subpotent Drug: Supplier indicated assay results did not meet specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.