US Drug Recall Register
Class III · Low risk Terminated Initiated Jun 29, 2015 (11 years ago)

HydrOXYzine Hydrochloride Tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

What was recalled

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

Recalling firm
Qualitest Pharmaceuticals
NDC code
0603-3968-21
Origin
AL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1239-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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