Entecavir Tablet
FDA Recall NDC 31722-834
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 Entecavir (NDC 31722-834). A significant event, classified as Class II, was initiated on Jul 20, 2017 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point."
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 Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Jul 20, 2017
Aug 23, 2017
5664 bottles
Recall Profile & Regulatory Data
Event ID
77846
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hetero USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ
Termination Date
Feb 27, 2019
Product Description
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
Batch or Lot Expiration Information
Lot# ENT17008, Exp 01/2019
Affected Packages Involved in this Recall
31722-833-30Product
31722-833-90Product
31722-833-31Product
31722-833-32Product
31722-834-30Product
31722-834-90Product
31722-834-31Product
31722-834-32Product
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.
