The Recall Desk

FDA (Drugs) recall action 83181

P & L Developments, LLC recalled 3 products on 2019-06-26

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-06-26
Critical
0
Units
344,244

Why these products were recalled

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).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • SevereFDA (Drugs)··2019-06-26

    P & L Developments Recalls Cetirizine HCL Oral Solution Due to Contamination

    P & L Developments, LLC is recalling 202,068 bottles of Cetirizine HCL Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-26

    P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination

    P & L Developments, LLC is recalling 17,664 bottles of Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-26

    P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination

    P & L Developments is recalling 124,512 bottles of Up & Up Children's Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia 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.
    Category
    Distribution
    0 states