Caraco Pharmaceutical Laboratories, Ltd. recalls Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat
Recalled May 7, 2014 · FDA recall D-1297-2014 · Caraco Pharmaceutical Laboratories
Hazard
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide · FDA Class III
Units
47,813 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
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
Manufacturer(s)
Caraco Pharmaceutical Laboratories, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →