Drug product
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
D-0342-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65,796 containers
- Official record key
drug-enforcement:D-0342-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot 0GR0445, Exp 1/31/2022; 0LR0361, Exp 4/30/2022; 1AR0558, Exp 7/31/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification