D-1129-2015 Class II Terminated
FDA drug recall D-1129-2015 was initiated by Akorn, Inc. on Apr 7, 2015 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Nov 29, 2017). Affected quantity: 424,174 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 17, 2015
- Initiation Date
- Apr 7, 2015
- Termination Date
- Nov 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 424,174 bottles
Product 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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide including Puerto Rico
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1129-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026