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
Reason for recall: Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Recall initiated: 20210702
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated