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. P

FDA recall notice · announced May 31, 2017 · Fagron

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547

Reason for recall

cGMP Deviations: lack of quality assurance at the API manufacturer.

Notes

Distribution: Nationwide in US and PR and Australia
Lot/code information: Lot #, Expiration Date: a) 16J05-U01-032346, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033898, Exp. 5/18/2018. b) 16F23-U04-031011, 16J05-U02-032345, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033897, 16J25-U05-034708, 16J25-U05-035527, Exp. 5/18/2018; c) 16F23-U04-031024, 16K16-U337-033665, 16G18-F003; 16G18-F003A, Exp. 5/17/2018. d) 16K16-U337-033664, 16G18-F003, Exp. 5/17/2018; 16J25-U05-034707, Exp. 5/18/2018.
Quantity: 1313 grams
Status: Terminated
Products in this recall event:
- 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 onl (D-0791-2017)
- 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 (D-0792-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.