The Harvard Drug Group recalls NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 5
Recalled July 21, 2021 · FDA recall D-0652-2021 · The Harvard Drug Group
Hazard
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. · FDA Class II
Units
504 Cartons of 50 count each; 372 Cartons of 100 count each
Sold at
Distributed in OH and NJ
Description
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
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
Manufacturer(s)
The Harvard Drug Group
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →