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 May 31, 2017 · FDA recall D-0791-2017 · Fagron
Hazard
cGMP Deviations: lack of quality assurance at the API manufacturer. · FDA Class II
Units
15283 grams
Sold at
Nationwide in US and PR and Australia
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), 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
Manufacturer(s)
Fagron, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →