Drug recall D-0334-2022
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 for recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Lots and codes
Lot a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022
Recall details
- Recalling firm
- Perrigo Company PLC, Allegan, MI
- Quantity
- 28776 containers
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 27, 2021
- Terminated
- November 8, 2022
Related products
- CareOne Allergy Relief – drug information
- NDC 41520-229 CareOne Allergy Relief · Fexofenadine Hydrochloride 180 mg/1 · American Sales Company