D-0345-2022 Class II Terminated
FDA drug recall D-0345-2022 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: 89,664 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
- 89,664 containers
Product Description
Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
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 0FR0563, Exp 02/28/22; 0GR0530, Exp 03/31/22; 0KR0434, 0KR0435, 0LR0366, 0LR0367, 0LR0368, Exp 06/30/22.