drugs Class III Updated 2014-05-07

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

Distribution: Nationwide (United States)
Lot/Code Info: JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
View official government recall

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