FDA recall D-1297-2014

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

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-04-09

Report date

2014-05-07

Termination date

2014-10-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Detroit, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1297-2014