Recall: D-0913-2023

Class II - Potentially Harmful

Class IIClassification

2023-07-05Initiated

TerminatedStatus

Teva Pharmaceuticals USA IncFirm

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

Reason

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

Distribution

Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.