D-0346-2022 Class II Terminated
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
- 41,472 containers
Product Description
Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 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# 0CR0510, Exp 09/30/21, 0GR0445, Exp 01/31/22, 0LR0361, Exp 04/30/22, 1AR0558 , Exp 07/31/22