Recalls / Class II

Class IID-0079-2018

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) 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

Affected 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

Why it was recalled

cGMP Deviations: lack of quality assurance at the API manufacturer.

Recalling firm

Firm

Fagron, Inc

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

2400 Pilot Knob Rd, N/A, Saint Paul, Minnesota 55120-1118

Distribution

Quantity

934 grams

Distribution pattern

Nationwide in USA

Timeline

Recall initiated

2017-10-25

FDA classified

2017-11-14

Posted by FDA

2017-11-22

Terminated

2018-05-11

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0079-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.