Home / Recalls / P & L Developments, LLC / D-1408-2019

D-1408-2019 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
17,664 bottles

Product Description

Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.

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: C04866; C09863, Exp. 10/19; F01267, Exp. 12/19; F12609, Exp. 2/20; F25327, 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-1409-2019 Class II — Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistam (June 5, 2019)
  • D-1407-2019 Class II — Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Fre (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)