Recalls / Class II
Class IID-1129-2015
Product
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
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 424,174 bottles
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2015-04-07
- FDA classified
- 2015-06-09
- Posted by FDA
- 2015-06-17
- Terminated
- 2017-11-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1129-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.