FDAFDA · Food and drugs·Recall number D-0079-2018
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
Published November 22, 2017 · Recall initiated: October 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: lack of quality assurance at the API manufacturer.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Fagron, Inc
- Distributor
- Nationwide in USA
- Lot
- Lot #, Expiration Date: a) 1 G bottle: 16F23-U05-033657, Exp. 5/26/2017. b) 5 G bottle: 16F23-U05-033656, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. c) 25 G bottle: 16F23-U05-033655, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. d) 100 G bottle: 17C02-U02-035888, Exp. 1/19/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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