FDA-Drug2017-11-22Class II
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) and 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
Fagron, Inc
Hazard
cGMP Deviations: lack of quality assurance at the API manufacturer.
Sold states
Nationwide in USA
Affected count
934 grams
Manufactured in
2400 Pilot Knob Rd, N/A, Saint Paul, MN, United States
Products
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) and 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0079-2018Don't want to check this manually?
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