D-0334-2022 Class II Terminated
FDA drug recall D-0334-2022 was initiated by Perrigo Company PLC on July 27, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. The recall status is terminated (terminated November 8, 2022). Affected quantity: 28776 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- January 12, 2022
- Initiation Date
- July 27, 2021
- Termination Date
- November 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28776 containers
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022