US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 6, 2017 (9 years ago)

Estrone

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

Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547

Recalling firm
Fagron, Inc
NDC code
51552-0445-2
Origin
MN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0792-2017

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 Estrone recalls

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Class II · Moderate risk Terminated

Estrone 5mg/mL Oil Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1195-2019
Class II · Moderate risk Terminated

Estrone USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8049-3 D-0491-2018
Class II · Moderate risk Terminated

Estrone USP

Reason cGMP Deviations; lack of quality assurance.

American Pharmaceutical Ingredients LLC D-0919-2017
Class II · Moderate risk Terminated

Estrone

Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Medisca, Inc. NDC 38779-0891-05 D-0664-2017
Class II · Moderate risk Terminated

Estrone Micronized

Reason cGMP Deviations; lack of quality assurance.

Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-003-04 D-0657-2017