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Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in...

FDA Recall #D-0345-2022 — Class II — July 27, 2021

Recall #D-0345-2022 Date: July 27, 2021 Classification: Class II Status: Terminated

Product Description

Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6

Reason for Recall

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

Recalling Firm

Perrigo Company PLC — Allegan, MI

Classification

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

Product Type

Drugs

Product Quantity

89,664 containers

Distribution

Nationwide in the USA

Code Information

Lot 0FR0563, Exp 02/28/22; 0GR0530, Exp 03/31/22; 0KR0434, 0KR0435, 0LR0366, 0LR0367, 0LR0368, Exp 06/30/22.

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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