Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceutic...

FDA Recall #D-0481-2024 — Class III — April 25, 2024

Recall #D-0481-2024 Date: April 25, 2024 Classification: Class III Status: Completed

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

Reason for Recall

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

Recalling Firm

Viatris Inc — Canonsburg, PA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

143,230 bottles

Distribution

Nationwide within the united states

Code Information

Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated