June 2015 FDA Recall Drug by Qualitest Pharmaceuticals
D-1239-2015 - Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

This Class III drug recall was voluntarily initiated by Qualitest Pharmaceuticals on June 29, 2015 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications; the identification codes on some tablets may be unreadable. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1239-2015

Reason for Recall
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Initiated
06-29-2015
Reported
07-22-2015
Quantity
47,376 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Qualitest Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-23-2016
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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