April 2024 FDA Recall Valacyclovir Hydrochloride by Viatris Inc
D-0481-2024 - Failed Tablet/Capsule Specifications
This Class III drug recall was voluntarily initiated by Viatris Inc on April 25, 2024 for the product Valacyclovir Hydrochloride. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0481-2024
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
04-25-2024
05-08-2024
143,230 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Viatris Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the united states
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
