RecallRadar

FDA Drug recall D-0334-2022

CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UP…

On 2022-01-12 the FDA classified a Class II recall of CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UP… by Perrigo, citing failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0334-2022
ClassificationClass II
Statusterminated
Initiated2021-07-27
Published2022-01-12
Last updated2026-09-13 11:52 UTC
CompanyPerrigo
DistributionUS

Product

CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic

Reason

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

Identifiers

upc341520319846
upc341520319839
ndc41520-229-95
ndc41520-229-39
ndc41520-229-22
code_infoLot a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0334-2022%22

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