Recalling firm
AvKARE
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide within the United States
Firm state
TN
Product quantity
20 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
Labeling: Label Mix-Up
Product description
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Code / lot info
Lot #: 100049501, Exp. Date 07/31/2026
Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.