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Over 344,000 Bottles of Cetirizine Recalled

June 27, 2019

Concerns about possible bacterial contamination have prompted P & L Developments to recall more than 344,000 bottles of grape-flavored cetirizine distributed by several different outlets. According to the June 26, 2019, US Food and Drug Administration (FDA) Enforcement Report, P & L Developments initiated the recall after learning of a recall issued by its supplier over potential Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii) contamination. 

Included in the recall are 4-ounce bottles of cetirizine HCL oral solution 1 mg/mL, children's allergy, antihistamine, dye-free, gluten-free, grape flavor, distributed throughout the United States by:

  • Dolgencorp, a subsidiary of Doller General (NDC 55910-878-04, UPC 359726178051), from lots C00138 and A48440 (Exp. 5/19); C02434 and C04186 (Exp. 6/19); C07864 (Exp. 7/19); F13277, C08962, and F13778 (Exp. 10/19); C11746, F05899, and F13777 (Exp. 12/19); F09356, F10784, and F13595 (Exp. 2/20); and F22355 and F23239 (Exp. 8/20);  
  • CDMA (Chain Drug Marketing Association), Quality Choice brand (NDC 63868-430-04, UPC 635515992474), from lots C04866 and C09863 (Exp. 10/19); F01267 (Exp. 12/19); F12609 (Exp. 2/20); and F25327 (Exp. 8/20); and 
  • Target Corporation, Up & Up brand (NDC 11673-178-04, UPC 359726178044), from lots A98495, C03882, and A49664 (Exp. 5/19); C06541 (Exp. 6/19); C05532 and F00527 (Exp. 10/19); F00528 and F07279 (Exp. 12/19); and F07842 and F10237 (Exp. 2/20).

P & L Developments voluntarily initiated the recall June 5, 2019. The FDA designated it Class II June 20, 2019. The classification suggests use of the medication could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.

Cetirizine is an over-the-counter antihistamine used to treat allergy, hives, and itching.

Jolynn Tumolo

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