Reported May 31, 2017 · Terminated
Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2),…
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?
- Estrone, For Prescription Compounding
- packaged in a) 1 G bottle (NDC
51552-0445-1)b) 5 G bottle (NDC 51552-0445-2)
- c) 25 G bottle (NDC51552-0445-4)
- d) 100 G bottle (NDC51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
- Also packaged asEstrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 16J05-U01-032346, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033898, Exp. 5/18/2018. 2 16F23-U04-031011, 16J05-U02-032345, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033897, 16J25-U05-034708, 16J25-U05-035527, Exp. 5/18/2018 3 16F23-U04-031024, 16K16-U337-033665, 16G18-F003; 16G18-F003A, Exp. 5/17/2018. 4 16K16-U337-033664, 16G18-F003, Exp. 5/17/2018; 16J25-U05-034707, Exp. 5/18/2018. - Amount recalled
- 1313 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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