FDA-Drug2022-11-23Class II

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

Viatris Inc
Hazard

Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.

Sold states
Nationwide in the USA
Affected count
2,794 bottles
Manufactured in
1000 Mylan Blvd, N/A, Canonsburg, PA, United States
Products
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0063-2023

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