Reported Jun 17, 2015 · Terminated
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W. Field Court, Suite 300 · Lake Forest, IL · 60045
Is this the product you have?
- 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
- Lot codes and dates
Lot# 620984620987Exp 04/2015621481621484621752621754 Exp 05/2015621875622239 Exp 06/2015622742622745623371 Exp 08/2015623374623820623823 Exp 09/2015624265624268 Exp 10/2015624824624827 Exp 11/2015625472625475 Exp 01/2016625783625786626447626450 02/2016627683627797 Exp 05/2016627800 Exp 06/2016629094629097629100629103 Exp 08/2016629928 Exp 09/2016629931630480630483 Exp 10/2016630874630877631513 Exp 12/2016
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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