Cetirizine Oral Solution 1 mg/mL recall: CGMP Deviations
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.
Why was Cetirizine Oral Solution 1 mg/mL 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: A98495; C03882; A49664, Exp. 5/19; C06541, Exp. 6/19; C05532; F00527, Exp. 10/19; F00528; F07279, Exp. 12/19; F07842; F10237, Exp. 2/20.
- 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.
- Recalling firm
- P & L Developments, LLC
- Quantity
- 124,512 bottles
- Distribution
- Nationwide in the U.S.
- Recall date
- June 26, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)