Drug product
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
D-0269-2022
Product summary
- Event
- Event 89042
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5016 cartons
- Official record key
drug-enforcement:D-0269-2022
Official wording
Reason: Failed dissolution specifications
Code information: Lot #: AC2103329F, Exp 1/2023
Distribution pattern: USA Nationwide.
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications