FDA-Drug2014-05-07Class III
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
Caraco Pharmaceutical Laboratories, Ltd.
Hazard
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Sold states
Nationwide
Affected count
47,813 bottles
Manufactured in
1150 Elijah McCoy Dr, Detroit, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1297-2014Don't want to check this manually?
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