December 2013 FDA Recall Drug by Qualitest Pharmaceuticals
D-394-2014 - Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

This Class III drug recall was voluntarily initiated by Qualitest Pharmaceuticals on December 16, 2013 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-394-2014

Reason for Recall
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Initiated
12-16-2013
Reported
01-08-2014
Quantity
438,055 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67102
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2014
Product Description About Product Description
Full technical description of the product.
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).

Batch or Lot Expiration Information

Lot# Lot Numbers: NDC 0603-9063-54 (120 mL): L081K12A, exp. 4/14; L082K12A, exp. 4/14; L062M12A, exp. 6/14; L063M12A, exp. 6/14; L064M12A, exp. 6/14; L054A13A, exp. 7/14; L055A13A, exp. 7/14; L057A13A, exp. 7/14; L058A13A, exp. 7/14; L075B13A, exp. 8/14; L076B13A, exp 8/14; L003C13A, exp. 8/14; L004C13A, exp. 8/14; and L005C13A, exp. 8/14 NDC 0603-9063-58 (480 mL): L081K12B, exp. 4/14; L082K12B, exp. 4/14; L059A13A, exp. 7/14; L114E13A, exp. 10/14; L026G13A, exp. 12/14; and L081J13A, exp. 3/15.