FDA recall D-0079-2018

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

Reason for recall

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

Distribution

Nationwide in USA

Key facts

Status

Terminated

Initiation date

2017-10-25

Report date

2017-11-22

Termination date

2018-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0079-2018