Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
Where it was sold
Nationwide within the united states
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0481-2024
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Apr 25, 2024
- FDA report date
- May 8, 2024
- Quantity
- 143,230 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0481-2024, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Completed
- Country
- United States
- Event ID
- 94482
- Address
- 1000 Mylan Blvd
- Code information
- Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
- Postal code
- 15317-5853
- Report date
- May 8, 2024
- Product type
- Drugs
- Recall number
- D-0481-2024
- Classification
- Class III
- Recalling firm
- Viatris Inc
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the united states
- Recall initiation date
- Apr 25, 2024
- Initial firm notification
- Letter
- Center classification date
- May 2, 2024