Drug product
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.
D-0909-2023
Product summary
- Event
- Event 91672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,904 cartons
- Official record key
drug-enforcement:D-0909-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: a) 2CR0652, 2DR0464, 2DR0465,Exp. Date 12/23; 2ER0285, Exp. Date 01/24. b) 2DR0466, Exp. Date 12/23; 2ER0412, Exp. Date 01/24; 2GR0330, Exp. Date 04/24
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications