🔍 RecallPedia

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

Class I - Dangerous
💊 Drugs Recalled: April 7, 2015 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot# 621637, 621640 Exp 05/2015; 622748, 622751 Exp 08/2015; 623599, 623602 Exp 09/2015; 624132, 624135 Exp 10/2015; 628282, 628285, 628288, 628291 Exp 06/2016; 628850, 628853, 628856, 628859 Exp 07/2016, 629797, 629800, 629803, 629806 Exp 09/2016
  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:
Akorn, Inc.
Reason for Recall:
Failed Impurities/Degradation Specifications
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

Product Codes/Lot Numbers:

Lot# 621637, 621640 Exp 05/2015; 622748, 622751 Exp 08/2015; 623599, 623602 Exp 09/2015; 624132, 624135 Exp 10/2015; 628282, 628285, 628288, 628291 Exp 06/2016; 628850, 628853, 628856, 628859 Exp 07/2016, 629797, 629800, 629803, 629806 Exp 09/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1129-2015

Related Recalls