Drug product
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
D-0272-2022
Product summary
- Event
- Event 89042
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2496 cartons
- Official record key
drug-enforcement:D-0272-2022
Official wording
Reason: Failed dissolution specifications
Code information: Lot #: AC2103329G, Exp 1/2023
Distribution pattern: USA Nationwide.
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications