Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

Recall Number: D-1361-2019

Firm: Torrent Pharma Inc

Classification: Class II

Status: Terminated

Report Date: 20190619

Initiation Date: 20190521

Termination Date: 20201006

Reason for Recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Product Description

Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD