Drug Enforcement D-0063-2023

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

Status

Terminated

Classification

Class II

Report Date

November 23, 2022

Termination Date

July 13, 2023

Product Information

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
Product quantity
2,794 bottles
Reason for recall
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Viatris Inc
Address
1000 Mylan Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0063-2023
Event ID
91038
Recall initiation date
October 21, 2022
Center classification date
November 16, 2022
Code info
Lot #: 3150116, Exp 2/2025
More code info
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