FDAClass IISeptember 25, 2019

Fexofenadine HCL Tablets USP recall: Impurity Out of Spec

Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured…

Why was Fexofenadine HCL Tablets USP recalled?

Failed Impurities/Degradation Specifications

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:067180011A, 067180012A, Exp 04/21, 06718027B1, Exp 09/21

Product
Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured…
Recalling firm
Aurolife Pharma, LLC
Quantity
6104 bottles
Distribution
Nationwide in the USA
Recall date
September 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls