Estriol recalled over manufacturing violations

Recall date

April 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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)…

Recall number

D-0791-2017

FDA classification

Class II

Brand / firm

Fagron, Inc

Sold / distributed

Nationwide in US and PR and Australia

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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