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

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

Code information: Lot #s: 17E015; 17E024; 17E044, Exp. 05/2019; 17F018, Exp. 06/2019; 17G012, Exp. 07/2019; 17K024, Exp. 10/2019; 17M004, Exp. 12/2019; 18B017, Exp. 02/2020; 18H023, Exp. 08/2020.

Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.