Estriol recall: CGMP Deviations
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), 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 Also packaged as: Estriol 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
Why was Estriol recalled?
cGMP Deviations: lack of quality assurance at the API manufacturer.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #, Expiration Date: a) 1 G bottle: 16D08-U02-030005, Exp. 3/6/2018; 16F23-U05-033657, Exp. 5/26/2018; 17C02-U02-035889, Exp. 1/19/2019. b) 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. c) 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. d) 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.
- 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), 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 Also packaged as: Estriol 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
- Recalling firm
- Fagron, Inc
- Quantity
- 15283 grams
- Distribution
- Nationwide in US and PR and Australia
- Recall date
- May 31, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)