FDAFDA · Food and drugs·Recall number D-0913-2023
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Published July 19, 2023 · Recall initiated: July 5, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SUNITINIB MALATE
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Distributor
- Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
- Lot
- Lot # 100037220, Exp 10/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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