Drug product
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
D-0379-2022
Product summary
- Event
- Event 89364
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,352 boxes
- Official record key
drug-enforcement:D-0379-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: AC2106452F, Exp. 3/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications