🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: October 25, 2017 Fagron Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Fagron, Inc
Reason for Recall:
cGMP Deviations: lack of quality assurance at the API manufacturer.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0079-2018

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