Drug product
Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
D-0268-2022
Product summary
- Event
- Event 89042
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14976 cartons
- Official record key
drug-enforcement:D-0268-2022
Official wording
Reason: Failed dissolution specifications
Code information: Lot #: AC2103329I, Exp 1/2023
Distribution pattern: USA Nationwide.
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications