Drug product
basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2
D-0331-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,320 containers
- Official record key
drug-enforcement:D-0331-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot # 0GR0528, Exp 03/31/22; 0KR0473, Exp 04/30/22; 0LR0369, Exp 06/30/22
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification