Drug product
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
D-0345-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89,664 containers
- Official record key
drug-enforcement:D-0345-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot 0FR0563, Exp 02/28/22; 0GR0530, Exp 03/31/22; 0KR0434, 0KR0435, 0LR0366, 0LR0367, 0LR0368, Exp 06/30/22.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification