Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations
Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
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 Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Failed impurities/ degradation specifications: Out of specification for organic impurities.
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