Product: 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
Reason for recall: cGMP Deviations: lack of quality assurance at the API manufacturer.
Recall initiated: 20170406
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated