FDAClass IISeptember 18, 2019

AVKARE Fexofenadine Hydrochloride Tablets USP recall

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

Why was AVKARE Fexofenadine Hydrochloride Tablets USP recalled?

Failed Stability 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. 04/2021; 06718027B1 Exp. 09/2021

Product
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Recalling firm
AVKARE Inc.
Quantity
5953 bottles
Distribution
Nationwide in the U.S.
Recall date
September 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls