Cetirizine Hydrochloride Syrup (Qualitest) – Impurity Found (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Qualitest Pharmaceuticals
Lot Codes / Batch Numbers
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.
Products Sold
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.
Qualitest Pharmaceuticals is recalling Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 due to Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026