Drug product
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
D-0384-2022
Product summary
- Event
- Event 89364
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,984 boxes
- Official record key
drug-enforcement:D-0384-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #s: 79C002624D; 79C002625C, Exp. 4/30/2022.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications