Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1,...
FDA Recall #D-0628-2020 — Class II — December 11, 2019
Product Description
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.
Reason for Recall
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Recalling Firm
Spectrum Laboratory Products — Gardena, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6.284 kg
Distribution
Nationwide in the USA and Canada
Code Information
Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.