FDAClass IIJuly 19, 2023

Sunitinib Malate Capsules recall

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

Why was Sunitinib Malate Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 100037220, Exp 10/2024

Product
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Recalling firm
Teva Pharmaceuticals USA Inc
Quantity
180 bottles
Distribution
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Recall date
July 19, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls