FDA recall D-0652-2021

The Harvard Drug Group · Class II · 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

Reason for recall

Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

Distribution

Distributed in OH and NJ

Key facts

Status: Terminated
Initiation date: 2021-07-02
Report date: 2021-07-21
Termination date: 2022-12-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2021