July 2021 FDA Recall Nifedipine by The Harvard Drug Group
D-0652-2021 - Failed Dissolution Specification

This Class II drug recall was voluntarily initiated by The Harvard Drug Group on July 2, 2021 for the product Nifedipine. The FDA reported the reason for recall as failed dissolution specification. The product was distributed in Distributed in OH and NJ and the recall is currently terminated.

Recall Number: D-0652-2021

Reason for Recall
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Initiated
07-02-2021
Reported
07-21-2021
Quantity
504 Cartons of 50 count each; 372 Cartons of 100 count each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88224
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in OH and NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022

Affected Packages Involved in this Recall

0904-7080-06 Nifedipine
0904-7080-61 Nifedipine
0904-7081-06 Nifedipine
0904-7081-61 Nifedipine
0904-7082-04 Nifedipine
0904-7082-06 Nifedipine