Class II · Moderate risk Terminated
Estriol 1mg/gm
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Estriol USP Micronized 5 G
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed impurities/ degradation specifications: Out of specification for organic impurities.
What was recalled
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
- Recalling firm
- Triova Pharmaceuticals LLC
- NDC code
- 71092-9977-02
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1284-2020
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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