FDAJune 5, 2019drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Terminated

Brands named

p l developments

UPCs

635515992474

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

FDAG&L Food Dried Bean Curd Net WT 17.6 OZ (500G) INGREDIENTS: Soybean, Water, Magnesium Chloride as Preservative CONTAINS: Soybean 121C was sterilized at high temperature PRODUCT OF CHINA U.S.A. Distributed By: G&L PRODUCE INC 1140 REVERE AVE SAN FRANCISCO CA 94124 UPC: 69763255602362025-09-16
FDABrand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood v...2025-05-16
FDASteamable by Lidl Chopped Spinach NET WT 12 OZ (340 g) UPC 4 056489 34380 6. Frozen product.2022-01-19
FDAGiant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases, also poly bags and cartons, 12/10 oz. bags per case and bulk 22 lbs. bags2021-11-30
FDANicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.2020-09-09
FDAA&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.2019-09-10
FDAA&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.2019-09-10
FDAA&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.2019-09-10

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