FDA Drug Class II — Moderate

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.

Hazard

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

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Products

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,
Brand
Spectrum Laboratory Products
UPC
Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021

Units Affected

6.284 kg

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