D-1130-2015 Class II Terminated
FDA drug recall D-1130-2015 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).
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 Description
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide including Puerto Rico
Code Information
Lot# 620984, 620987, Exp 04/2015; 621481, 621484, 621752, 621754 Exp 05/2015; 621875, 622239 Exp 06/2015; 622742, 622745, 623371 Exp 08/2015; 623374, 623820, 623823 Exp 09/2015; 624265, 624268 Exp 10/2015; 624824, 624827 Exp 11/2015; 625472, 625475 Exp 01/2016; 625783, 625786, 626447, 626450 02/2016; 627683, 627797 Exp 05/2016; 627800 Exp 06/2016; 629094, 629097, 629100, 629103 Exp 08/2016; 629928 Exp 09/2016; 629931, 630480, 630483 Exp 10/2016; 630874, 630877, 631513 Exp 12/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1130-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026