FDA Recall Terminated Historical recordClass II
allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lakeland, FL 33811, Made in the Czech Republic
- Reason
- Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- Published
- January 12, 2022
- Distribution
- Nationwide
