Reported Nov 22, 2017 · Terminated
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC:…
Fagron, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fagron, Inc · 2400 Pilot Knob Rd · Saint Paul, MN · 55120-1118
Is this the product you have?
- Estriol, For Prescription Compounding
- packaged in a) 1 G bottle (NDC51552-1392-1)
- b) 5 G bottle (NDC51552-1392-2)
- c) 25 G bottle (NDC51552-1392-3) 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
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 1 G bottle: 16F23-U05-033657, Exp. 5/26/2017. 2 5 G bottle: 16F23-U05-033656, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. 3 25 G bottle: 16F23-U05-033655, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. 4 100 G bottle: 17C02-U02-035888, Exp. 1/19/2019 - Amount recalled
- 934 grams
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations: lack of quality assurance at the API manufacturer.
This product could cause temporary or reversible health problems — stop using it.
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