Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

Recall Number: D-0913-2023

Firm: Teva Pharmaceuticals USA Inc

Classification: Class II

Status: Terminated

Report Date: 20230719

Initiation Date: 20230705

Termination Date: 20240110

Reason for Recall

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Product Description

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28