D-0341-2022 Class II Terminated
FDA drug recall D-0341-2022 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: 48,816 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
- 48,816 containers
Product Description
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
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 0LE2178, Exp 1/31/2022; 0ME2516, Exp 4/30/2022