Drug product
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
D-0652-2021
Product summary
- Event
- Event 88224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
- Official record key
drug-enforcement:D-0652-2021
Official wording
Reason: Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Code information: Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
Distribution pattern: Distributed in OH and NJ
Derived failure modes
-
Potency or specification failure
Out of specification