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D-0481-2024Class III

Viatris Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Viatris Inc
Product type
Drug
Status
Completed
Report date
2024-05-08
Distribution
Nationwide within the united states
Firm state
PA
Product quantity
143,230 bottles
Initiated by
Voluntary: Firm initiated
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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →