Fenofibrate Tablet, Film Coated
FDA Recall NDC 31722-596
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 Fenofibrate (NDC 31722-596). A significant event, classified as Class III, was initiated on Sep 12, 2018 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg."
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 III Terminated
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Sep 12, 2018
Oct 03, 2018
5,424 bottles
Recall Profile & Regulatory Data
Event ID
81017
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Indiana and Louisiana
Termination Date
Nov 29, 2018
Product Description
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Batch or Lot Expiration Information
Lot# : E181370, Exp. 5/2020
Affected Packages Involved in this Recall
31722-595-30Product
31722-595-90Product
31722-595-31Product
31722-595-32Product
31722-596-30Product
31722-596-90Product
31722-596-31Product
31722-596-32Product
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.
