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Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bot...

FDA Recall #D-0079-2018 — Class II — October 25, 2017

Recall #D-0079-2018 Date: October 25, 2017 Classification: Class II Status: Terminated

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) 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

Reason for Recall

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

Recalling Firm

Fagron, Inc — Saint Paul, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

934 grams

Distribution

Nationwide in USA

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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