Drug product
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.
D-0267-2022
Product summary
- Event
- Event 89042
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4896 cartons
- Official record key
drug-enforcement:D-0267-2022
Official wording
Reason: Failed dissolution specifications
Code information: Lot #: AC2103329E, Exp 1/2023
Distribution pattern: USA Nationwide.
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications