Drug product
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India
D-0073-2023
Product summary
- Event
- Event 91190
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25,176, 30-count; 22,968 20-count
- Official record key
drug-enforcement:D-0073-2023
Official wording
Reason: Failed dissolution specifications
Code information: Lot# (a) AC2203133B, EXP 01/2024; (b) AC2203133A, EXP 01/2024.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications