Caraco Pharmaceutical Laboratories, Ltd. recalls Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg,
Recalled Product
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Hazard / Issue
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Issued by
FDA
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