Felodipine Tablet, Extended Release
FDA Recall NDC 23155-049
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 Felodipine (NDC 23155-049). A significant event, classified as Class III, was initiated on Oct 23, 2020 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A"
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
October 2020 Class III Recall: Failed impurities/ degradation specifications
Recall Number
Class III Terminated
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Oct 23, 2020
Dec 02, 2020
7176 bottles
Recall Profile & Regulatory Data
Event ID
86659
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jan 28, 2022
Product Description
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
Batch or Lot Expiration Information
Lot# : 18029979, Exp 1/2021
Affected Packages Involved in this Recall
23155-048-01Product
23155-048-05Product
23155-049-01Product
23155-049-05Product
23155-050-01Product
23155-050-05Product
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.
