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…
- FDA Drug
- Class II
- terminated
- Published 2022-01-12
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
| Agency | FDA Drug |
|---|---|
| Recall number | D-0334-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-27 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Perrigo |
| Distribution | US |
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
| upc | 341520319846 |
|---|---|
| upc | 341520319839 |
| ndc | 41520-229-95 |
| ndc | 41520-229-39 |
| ndc | 41520-229-22 |
| code_info | Lot 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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