Reported Jan 8, 2014 · Terminated

Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx…

Qualitest Pharmaceuticals

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216

Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg
forQualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL)

Lot codes and dates: 19 of 19 products
Products covered by this recall
# Product as published
1 NDC 0603-9063-54 (120 mL): L081K12A, exp. 4/14
2 L082K12A, exp. 4/14
3 L062M12A, exp. 6/14
4 L063M12A, exp. 6/14
5 L064M12A, exp. 6/14
6 L054A13A, exp. 7/14
7 L055A13A, exp. 7/14
8 L057A13A, exp. 7/14
9 L058A13A, exp. 7/14
10 L075B13A, exp. 8/14
11 L076B13A, exp 8/14
12 L003C13A, exp. 8/14
13 L004C13A, exp. 8/14
14 and L005C13A, exp. 8/14 NDC 0603-9063-58 (480 mL): L081K12B, exp. 4/14
15 L082K12B, exp. 4/14
16 L059A13A, exp. 7/14
17 L114E13A, exp. 10/14
18 L026G13A, exp. 12/14
19 and L081J13A, exp. 3/15.
Amount recalled: 438,055 bottles

Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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12 in total.