Valacyclovir Tablet, Film Coated
FDA Recall NDC 31722-705
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 Valacyclovir (NDC 31722-705). A significant event, classified as Class II, was initiated on Feb 13, 2018 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018)."
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: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Feb 13, 2018
Mar 21, 2018
48132 60-count bottles
Recall Profile & Regulatory Data
Event ID
79142
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ and then distributed Nationwide in the USA
Termination Date
Feb 18, 2021
Product Description
Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30
Batch or Lot Expiration Information
Lot# VLC17027 Exp 07-2019
Affected Packages Involved in this Recall
31722-704-30Product
31722-704-60Product
31722-704-90Product
31722-704-01Product
31722-704-05Product
31722-704-31Product
31722-704-32Product
31722-705-30Product
31722-705-60Product
31722-705-90Product
31722-705-01Product
31722-705-05Product
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.
