FDA Recall Terminated Historical recordClass II
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
- Reason
- Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- Published
- January 12, 2022
- Distribution
- Nationwide
