Torrent Pharma Inc recalls Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
Recalled June 19, 2019 · FDA recall D-1361-2019 · Torrent Pharma
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
361,260 bottles
Sold at
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Description
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
Manufacturer(s)
Torrent Pharma Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →