NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton,...
FDA Recall #D-0652-2021 — Class II — July 2, 2021
Product Description
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.
Recalling Firm
The Harvard Drug Group — Livonia, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
504 Cartons of 50 count each; 372 Cartons of 100 count each
Distribution
Distributed in OH and NJ
Code Information
Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated