P & L Developments, LLC recalls Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (
Recalled June 26, 2019 · FDA recall D-1409-2019 · P & L Developments
Hazard
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
124,512 bottles
Sold at
Nationwide in the U.S.
Description
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.
Manufacturer(s)
P & L Developments, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →