FDA-Drug2017-05-31Class II
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 5
Fagron, Inc
Hazard
cGMP Deviations: lack of quality assurance at the API manufacturer.
Sold states
Nationwide in US and PR and Australia
Affected count
1313 grams
Manufactured in
2400 Pilot Knob Rd, Saint Paul, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0792-2017Don't want to check this manually?
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