D-0791-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- April 6, 2017
- Termination Date
- July 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15283 grams
Product Description
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
Reason for Recall
cGMP Deviations: lack of quality assurance at the API manufacturer.
Distribution Pattern
Nationwide in US and PR and Australia
Code Information
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.