Home / Recalls / P & L Developments, LLC / D-1407-2019

D-1407-2019 Class II Terminated

Recalled by P & L Developments, LLC — Westbury, NY

Recall Details

Product Type
Drugs
Report Date
June 26, 2019
Initiation Date
June 5, 2019
Termination Date
September 9, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
202,068 bottles

Product Description

Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.

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 Pattern

Nationwide in the U.S.

Code Information

Lot #s: C00138; A48440, Exp. 5/19; C02434; C04186, Exp. 6/19; C07864, Exp. 7/19; F13277; C08962; F13778, Exp. 10/19; C11746; F05899; F13777, Exp. 12/19; F09356; F10784; F13595, Exp. 2/20; F22355; F23239, Exp. 8/20.

Other recalls by P & L Developments, LLC

  • D-0004-2021 Class III — Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per (September 9, 2020)
  • D-1408-2019 Class II — Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, G (June 5, 2019)
  • D-1409-2019 Class II — Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistam (June 5, 2019)
  • D-1298-2014 Class III — Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and p (April 15, 2014)
  • D-1254-2014 Class III — Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan (April 14, 2014)