Drug Enforcement D-0103-2025

Labeling: Label Mix-Up

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

—

Product Information

Product description
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Product quantity
40 bottles
Reason for recall
Labeling: Label Mix-Up
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

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

Codes & Dates

Recall number
D-0103-2025
Event ID
95596
Recall initiation date
October 18, 2024
Center classification date
December 4, 2024
Code info
Lot #: 100049371, Exp. Date 07/31/2026
More code info
—