Drug Enforcement D-0481-2024

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

Status

Completed

Classification

Class III

Report Date

May 8, 2024

Termination Date

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Product Information

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
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the united states

Location & Firm

Recalling firm
Viatris Inc
Address
1000 Mylan Blvd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0481-2024
Event ID
94482
Recall initiation date
April 25, 2024
Center classification date
May 2, 2024
Code info
Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
More code info
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