Reported Oct 31, 2018 · Terminated

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by…

Lannett Company, 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: Lannett Company, Inc. · 9000 State Rd · Philadelphia, PA · 19136-1615

Is this the product you have?

  • HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
Lot codes and dates
    • Lot #: 1097
    • Exp 10/18
Amount recalled
8,324 bottles

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 22, 2019 · Data as of Sep 19, 6:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.