FDA recall D-394-2014

Qualitest Pharmaceuticals · Class III · drug

Product

Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).

Reason for recall

Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-12-16
Report date: 2014-01-08
Termination date: 2014-10-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-394-2014