Drug product
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
D-0906-2023
Product summary
- Event
- Event 91672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,688 cartons
- Official record key
drug-enforcement:D-0906-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: a) 2JE1882, Exp. date 01/24 b) 2FV1918, 2ER0411, Exp. date 01/24; 2GV1902, Exp. date 04/24; 2CR0652, 2DR0465, Exp. date 12/23; 2GR0329, Exp. date 04/24 c)2CR0653, 2DR0466, Exp. date 12/23; 2ER0287, 2ER0412, Exp. date 01/24
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications