PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 22, 2015 Initiated: June 29, 2015 #D-1239-2015

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Qualitest Pharmaceuticals
Units Affected
47,376 bottles
Distribution
Nationwide
Location
Huntsville, AL

Frequently Asked Questions

What product 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. Recalled by Qualitest Pharmaceuticals. Units affected: 47,376 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Which agency issued this recall?
This recall was issued by the FDA Drug on July 22, 2015. Severity: Low. Recall number: D-1239-2015.