FDA Drug recall D-0350-2022
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC…
- FDA Drug
- Class II
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC… 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-0350-2022 |
| 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
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic,
Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Identifiers
| upc | 036800332775 |
|---|---|
| upc | 036800332782 |
| upc | 036800332805 |
| upc | 036800332829 |
| code_info | Lot # a) 0KE2429, Exp 02/28/2022; b) 0HE2530, Exp 12/31/2021; c)0FR0460, Exp 02/28/2022; d)0GR0531, Exp 03/31/2022 ; 0KR0465, Exp 04/302022 |
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-0350-2022%22
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