FDA-Drug2014-05-07Class III
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
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
128,363 bottles
Manufactured in
1150 Elijah McCoy Dr, Detroit, MI, United States
Products
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1296-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief