Caraco Pharmaceutical Laboratories, Ltd.: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Agency Publication Date: May 1, 2014

Affected Products

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

JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15

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

JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67971

Status: Resolved

Manufacturer: Caraco Pharmaceutical Laboratories, Ltd.

Manufactured In: United States

Units Affected: 2 products (128,363 bottles; 47,813 bottles)

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Sources: FDA iRES · Raw API Response

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