Class II
Terminated
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) 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
- Company
- Fagron, Inc
- Recall Initiated
- October 25, 2017
- Posted
- November 22, 2017
- Recall Number
- D-0079-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 934 grams
- Firm Location
- Saint Paul, MN, United States
Reason for Recall
cGMP Deviations: lack of quality assurance at the API manufacturer.
Distribution
Nationwide in USA
Lot / Code Info
Lot #, Expiration Date: a) 1 G bottle: 16F23-U05-033657, Exp. 5/26/2017. b) 5 G bottle: 16F23-U05-033656, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. c) 25 G bottle: 16F23-U05-033655, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. d) 100 G bottle: 17C02-U02-035888, Exp. 1/19/2019
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