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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 gla

Recalled January 1, 2020 · FDA recall D-0628-2020 · Spectrum Laboratory Products

Hazard
Subpotent Drug: Supplier indicated assay results did not meet specifications. · FDA Class II
Units
6.284 kg
Sold at
Nationwide in the USA and Canada

Description

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

Product
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.
Manufacturer(s)
Spectrum Laboratory Products

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov