Why it was recalled
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Product description
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
Lot numbers, UPCs & expiration codes
Lot #: 3150116, Exp 2/2025
Where it was sold
Nationwide in the USA
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-0063-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 21, 2022
- FDA report date
- Nov 23, 2022
- Quantity
- 2,794 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0063-2023, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 91038
- Address
- 1000 Mylan Blvd
- Code information
- Lot #: 3150116, Exp 2/2025
- Postal code
- 15317-5853
- Report date
- Nov 23, 2022
- Product type
- Drugs
- Recall number
- D-0063-2023
- Classification
- Class II
- Recalling firm
- Viatris Inc
- Product quantity
- 2,794 bottles
- Termination date
- Jul 13, 2023
- Reason for recall
- Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 21, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 16, 2022