FDA recall D-0481-2024

Viatris Inc · Class III · drug

Product

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.

Distribution

Nationwide within the united states

Key facts

Status
Completed
Initiation date
2024-04-25
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0481-2024