RecallDepth
Class II Terminated

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.

Company
P & L Developments, Llc
Recall Initiated
June 5, 2019
Posted
June 26, 2019
Recall Number
D-1409-2019
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
124,512 bottles
Firm Location
Westbury, NY, United States

Reason for Recall

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).

Distribution

Nationwide in the U.S.

Lot / Code Info

Lot #s: A98495; C03882; A49664, Exp. 5/19; C06541, Exp. 6/19; C05532; F00527, Exp. 10/19; F00528; F07279, Exp. 12/19; F07842; F10237, Exp. 2/20.

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