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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
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