Hydroxyzine Hydrochloride recall: Impurity Out of Spec
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…
Why was Hydroxyzine Hydrochloride recalled?
Failed Impurities/Degradation Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Akorn, Inc.
- Quantity
- N/A
- Distribution
- Nationwide including Puerto Rico
- Recall date
- June 17, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)