D-0063-2023 Class II Terminated
FDA drug recall D-0063-2023 was initiated by Viatris Inc on October 21, 2022 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. The recall status is terminated (terminated July 13, 2023). Affected quantity: 2,794 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 23, 2022
- Initiation Date
- October 21, 2022
- Termination Date
- July 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,794 bottles
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
Reason for Recall
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 3150116, Exp 2/2025