Home / Recalls / Spectrum Laboratory Products / D-0628-2020

D-0628-2020 Class II Terminated

Recalled by Spectrum Laboratory Products — Gardena, CA

Recall Details

Product Type
Drugs
Report Date
January 1, 2020
Initiation Date
December 11, 2019
Termination Date
August 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6.284 kg

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.

Distribution Pattern

Nationwide in the USA and Canada

Code Information

Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021

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  • D-0881-2017 Class II — Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant (April 13, 2017)
  • D-1456-2016 Class II — Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, (August 1, 2016)
  • D-0255-2015 Class II — Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., (July 18, 2014)