FDAClass IIJanuary 12, 2022

Kroger Allergy Relief recall: Impurity Out of Spec

Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2

Why was Kroger Allergy Relief recalled?

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

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 0LE2178, Exp 1/31/2022; 0ME2516, Exp 4/30/2022

Product
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
Recalling firm
Perrigo Company PLC
Quantity
48,816 containers
Distribution
Nationwide in the USA
Recall date
January 12, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls