FDA recall D-1296-2014

Caraco Pharmaceutical Laboratories, Ltd. · Class III · drug

Product

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

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-1296-2014