FDA-Drug2015-07-22Class III

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

Qualitest Pharmaceuticals
Hazard

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

Sold states
Nationwide
Affected count
47,376 bottles
Manufactured in
120 Vintage Dr NE, N/A, Huntsville, AL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1239-2015

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