The Recall Desk
LowFDA (Drugs)·D-394-2014·Announced 2014-01-08

Qualitest Recalls Cetirizine Hydrochloride Syrup Due to Impurity Failure

Qualitest Pharmaceuticals is recalling 438,055 bottles of Cetirizine Hydrochloride Syrup because the product failed impurity specifications for 4-chlorobenzophenone.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Plain-English summary

Qualitest Pharmaceuticals is recalling 438,055 bottles of Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL in 120 mL and 480 mL bottles. The recall was initiated because the product failed impurities and degradation specifications, specifically being out of specification for the known impurity 4-chlorobenzophenone.

The affected product is prescription-only and was distributed nationwide and in Puerto Rico. The recall covers specific lot numbers for both the 120 mL (NDC 0603-9063-54) and 480 mL (NDC 0603-9063-58) bottle sizes, with expiration dates ranging from April 2014 to March 2015.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or return instructions.

The recalled product

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).
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Antihistamine
Hazard
Affected units
438,055

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Numbers: NDC 0603-9063-54 (120 mL): L081K12A
  • exp. 4/14
  • L082K12A
  • L062M12A
  • exp. 6/14
  • L063M12A
  • L064M12A
  • L054A13A
  • exp. 7/14
  • L055A13A
  • L057A13A
  • L058A13A
  • L075B13A
  • exp. 8/14
  • L076B13A
  • exp 8/14
  • L003C13A
  • L004C13A
  • and L005C13A
  • exp. 8/14 NDC 0603-9063-58 (480 mL): L081K12B

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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