drugs Class III Updated 2014-05-07

Caraco Pharmaceutical Laboratories, Ltd. recalls Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bo

Recalled Product

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

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: JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
View official government recall

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