Cetirizine Oral Solution 1 mg/mL recalled over manufacturing violations

Recall date

June 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

P & L Developments, LLC recalls Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distribu…

Recall number

D-1408-2019

FDA classification

Class II

Brand / firm

P & L Developments, LLC

Sold / distributed

Nationwide in the U.S.

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.