PlainRecalls
FDA Drug Moderate Class II Terminated

Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

Reported: November 23, 2022 Initiated: October 21, 2022 #D-0063-2023

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.

Details

Recalling Firm
Viatris Inc
Units Affected
2,794 bottles
Distribution
Nationwide in the USA
Location
Canonsburg, PA

Frequently Asked Questions

What product was recalled?
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05. Recalled by Viatris Inc. Units affected: 2,794 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 23, 2022. Severity: Moderate. Recall number: D-0063-2023.