Class II · Moderate risk Terminated
Estriol 1mg/gm
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Estriol
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: Supplier indicated assay results did not meet specifications.
What was recalled
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.
- Recalling firm
- Spectrum Laboratory Products
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0628-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Estriol recalls
See all
Class II · Moderate risk Terminated
Estriol 1mg/gm
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Estriol USP41 Micro 25 Grams
Reason cGMP Deviations
Class II · Moderate risk Terminated
Estriol 8 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Estriol 6 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
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