Caraco Pharmaceutical Laboratories, Ltd. recalls Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47
Recalled May 7, 2014 · FDA recall D-1296-2014 · Caraco Pharmaceutical Laboratories
Hazard
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide · FDA Class III
Units
128,363 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Product
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Manufacturer(s)
Caraco Pharmaceutical Laboratories, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →