Drug recall D-0913-2023
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 for recall
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Lots and codes
Lot # 100037220, Exp 10/2024
Recall details
- Recalling firm
- Teva Pharmaceuticals USA Inc, Parsippany, NJ
- Quantity
- 180 bottles
- Distribution
- Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 5, 2023
- Terminated
- January 10, 2024
Related products
- Sunitinib Malate – drug information
- NDC 0093-8199 Sunitinib Malate · Sunitinib Malate 12.5 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-8229 Sunitinib Malate · Sunitinib Malate 37.5 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-8224 Sunitinib Malate · Sunitinib Malate 25 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-8231 Sunitinib Malate · Sunitinib Malate 50 mg/1 · Teva Pharmaceuticals USA, Inc.