Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
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.
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason cGMP Deviations
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
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