Recall: D-0652-2021

Class II - Potentially Harmful

Class IIClassification

2021-07-02Initiated

TerminatedStatus

The Harvard Drug GroupFirm

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

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

Distribution

Distributed in OH and NJ

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.