Fagron, Inc recalls Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2)
Recalled November 22, 2017 · FDA recall D-0079-2018 · Fagron
Hazard
cGMP Deviations: lack of quality assurance at the API manufacturer. · FDA Class II
Units
934 grams
Sold at
Nationwide in USA
Description
cGMP Deviations: lack of quality assurance at the API manufacturer.
Product
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
Manufacturer(s)
Fagron, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →