FDA Drug recall D-1129-2015
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA b…
- FDA Drug
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA b… by Akorn, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1129-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-07 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lot# 621637, 621640 Exp 05/2015; 622748, 622751 Exp 08/2015; 623599, 623602 Exp 09/2015; 624132, 624135 Exp 10/2015; 62…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1129-2015%22
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