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AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 4...

FDA Recall #D-1875-2019 — Class II — August 28, 2019

Recall #D-1875-2019 Date: August 28, 2019 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Failed Stability Specifications.

Recalling Firm

AVKARE Inc. — Pulaski, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

5953 bottles

Distribution

Nationwide in the U.S.

Code Information

Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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