FDAFDA · Food and drugs·Recall number D-0628-2020
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.
Published January 1, 2020 · Recall initiated: December 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Supplier indicated assay results did not meet specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spectrum Laboratory Products
- Distributor
- Nationwide in the USA and Canada
- Lot
- Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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