Reported May 31, 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)
- d) 100 G bottle (NDC51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
- Also packaged asEstriol 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
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 1 G bottle: 16D08-U02-030005, Exp. 3/6/2018; 16F23-U05-033657, Exp. 5/26/2018; 17C02-U02-035889, Exp. 1/19/2019. 2 5 G bottle: 16D08-U02-030004, 16D08-U02-032486, Exp. 3/6/2018; 16F23-U05-033656, 16F23-U05-035093, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. 3 25 G bottle: 16D08-U02-030003, 16D08-U02-032475, Exp. 3/6/2018; 16F23-U05-033655, 16F23-U05-035092, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. 4 100 G bottle: 16D08-U02-030002, 16D08-U02-032474, Exp. 3/6/2018; 16F23-U05-031158,16F23-U05-033654, 16F23-U05-035091,16G18-F002, Exp. 5/26/2018; 17C02-U02-035888, Exp. 1/19/2019. - Amount recalled
- 15283 grams
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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