Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV
Summary
The FDA issued a Class III for Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: M by Viatris Inc. Reason: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets..
Details
Source
Drug Recall
External ID
D-0481-2024
Action Date
2024-05-08
Status
Completed
Category
drug
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
Lot/Code Info: Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
Quantity Affected: 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.
Distribution
Nationwide within the united states
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-25
Company
Canonsburg, PA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 86 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Viatris Inc has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Viatris Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Viatris Inc have FDA actions?
Viatris Inc has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0481-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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