FDA-Drug2021-07-21Class II
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
The Harvard Drug Group
Hazard
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Sold states
Distributed in OH and NJ
Affected count
504 Cartons of 50 count each; 372 Cartons of 100 count each
Manufactured in
17187 N Laurel Park Dr Ste 300, Livonia, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2021Don't want to check this manually?
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