Drug product
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
D-0273-2022
Product summary
- Event
- Event 89042
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0273-2022
Official wording
Reason: Failed dissolution specifications
Code information: Lot #: AC2103329C, Exp 1/2023
Distribution pattern: USA Nationwide.
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications