Home / Recalls / AvKARE / D-0103-2025

D-0103-2025 Class II Ongoing

Recalled by AvKARE — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
December 11, 2024
Initiation Date
October 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 bottles

Product Description

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

Reason for Recall

Labeling: Label Mix-Up

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 100049371, Exp. Date 07/31/2026

Other recalls by AvKARE

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  • D-0007-2026 Class II — Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.02 (September 2, 2025)
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  • D-0528-2025 Class III — Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av (June 26, 2025)
  • D-0529-2025 Class III — Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av (June 26, 2025)
  • D-0460-2025 Class II — Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Ma (May 13, 2025)
  • D-0461-2025 Class II — Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton (May 9, 2025)
  • D-0229-2025 Class II — Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pul (February 4, 2025)