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Recall Observatory FDA recall evidence

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

D-0481-2024

April 25, 2024

Class III

Product summary

Firm
Viatris Inc
Event
Event 94482
Status
Completed
Classification
Class III
Quantity
143,230 bottles
Official record key
drug-enforcement:D-0481-2024

Official wording

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

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

Distribution pattern: Nationwide within the united states

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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