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FDAFDA · Food and drugs·Recall number D-1239-2015

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

Published July 22, 2015 · Recall initiated: June 29, 2015

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Qualitest Pharmaceuticals
Distributor
Nationwide
Lot
100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 0603-3968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16
Risk classification
Class III
Area (FDA)
drug
Country
United States

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