Viatris Inc: Drug Recall

Recall #D-0481-2024 · 04/25/2024

Class III: Low Risk

Recall Details

Recall Number: D-0481-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Viatris Inc
Status: Completed
Date Initiated: 04/25/2024
Location: Canonsburg, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 143,230 bottles

Reason for Recall

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

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

Distribution Pattern

Nationwide within the united states

Other Recalls by Viatris Inc

Class II: Risk 12/23/2024

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II: Risk 12/23/2024

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained

View all recalls by Viatris Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.