FDA recall D-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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-10-21

Report date

2022-11-23

Termination date

2023-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

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