Famciclovir Tablet, Film Coated
FDA Recall NDC 31722-708
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 Famciclovir (NDC 31722-708). A significant event, classified as Class II, was initiated on Dec 22, 2017 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution."
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
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Dec 22, 2017
Feb 21, 2018
8,436 bottles
Recall Profile & Regulatory Data
Event ID
78811
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Feb 05, 2020
Product Description
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Batch or Lot Expiration Information
Lot# FMC17039, Exp 07/2019.
Affected Packages Involved in this Recall
31722-706-30Product
31722-706-60Product
31722-706-01Product
31722-706-05Product
31722-706-10Product
31722-707-30Product
31722-707-60Product
31722-707-01Product
31722-707-05Product
31722-707-10Product
31722-708-30Product
31722-708-60Product
31722-708-01Product
31722-708-05Product
31722-708-10Product
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.
