Recalls / Class II
Class IID-0063-2023
Product
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
- Affected lot / code info
- Lot #: 3150116, Exp 2/2025
Why it was recalled
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Recalling firm
- Firm
- Viatris Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, N/A, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 2,794 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-10-21
- FDA classified
- 2022-11-16
- Posted by FDA
- 2022-11-23
- Terminated
- 2023-07-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0063-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.