Nifedipine Tablet, Extended Release
FDA Recall NDC 0904-7082
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nifedipine (NDC 0904-7082). A significant event, classified as Class II, was initiated on Jul 02, 2021 by Major Pharmaceuticals. The reported reason for this action was: "Failed Dissolution Specification: Out of specification for dissolution during routine stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Jul 02, 2021
Jul 21, 2021
504 Cartons of 50 count each; 372 Cartons of 100 count each
Recall Profile & Regulatory Data
Event ID
88224
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in OH and NJ
Termination Date
Dec 28, 2022
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
Batch or Lot Expiration Information
Lot# Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
Affected Packages Involved in this Recall
0904-7080-06Product
0904-7080-61Product
0904-7081-06Product
0904-7081-61Product
0904-7082-04Product
0904-7082-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
