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
cGMP Deviations: lack of quality assurance at the API manufacturer.
What was recalled
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011
- Recalling firm
- Fagron, Inc
- NDC code
- 52372-9292-01
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0791-2017
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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