Qualitest Pharmaceuticals recalls HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1…

Recall date

June 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1239-2015

FDA classification

Class III

Brand / firm

Qualitest Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

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