FDAClass IIJanuary 12, 2022

Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride recall: Impurity Out of Spec

Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011

Why was Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride 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 # a) 1BR0462, Exp 10/31/2022 b) 0GR0528, Exp 3/31/2022; 0KR0473, Exp 4/30/2022; 0LR0369, Exp 6/30/2022

Product
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011
Recalling firm
Perrigo Company PLC
Quantity
44,688 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