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)…

Recall date

July 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0652-2021

FDA classification

Class II

Brand / firm

The Harvard Drug Group

Sold / distributed

Distributed in OH and NJ

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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