Drug product
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403.
D-0910-2023
Product summary
- Event
- Event 91672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 208,416 cartons
- Official record key
drug-enforcement:D-0910-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: a) 2HE2032, 2JE1882, 2JE2185 Exp. Date 01/24; b) 2DR0464, 2ER0410, Exp. Date 12/23; 2ER0286, 2ER0411, Exp. Date 01/24 c) 2DR0467, 2DR0468, 2DR0469, 2ER0288, Exp. Date 12/23 d) 2ER0414, Exp. Date 01/24, 2GR0333, Exp. Date 02/24
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications