Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Estriol USP41 Micro 25 Grams
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
46144-0300-01
Compare with the code on your package — it is the most precise check available.
Drug: Estriol
- Recalling firm
- API Solutions Inc.
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0695-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Estriol recalls
See all
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol 8 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 6 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol USP Micronized 5 G
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Other recalls by API Solutions Inc.
All 2021 recalls
Class II · Moderate risk
Azelaic Acid 99.0+% Micro 500 Grams
cGMP Deviations
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