Valacyclovir Hydrochloride Tablet, Film Coated
FDA Recall NDC 0378-4276
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 Hydrochloride (NDC 0378-4276). A significant event, classified as Class III, was initiated on Apr 25, 2024 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Apr 25, 2024
May 08, 2024
143,230 bottles
Recall Profile & Regulatory Data
Event ID
94482
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the united states
Product Description
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Batch or Lot Expiration Information
Lot# : 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
Affected Packages Involved in this Recall
0378-4275-93Product
0378-4275-77Product
0378-4276-93Product
0378-4276-77Product
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.
