Drug 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
D-0913-2023
Product summary
- Event
- Event 92636
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 bottles
- Official record key
drug-enforcement:D-0913-2023
Official wording
Reason: Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Code information: Lot # 100037220, Exp 10/2024
Distribution pattern: Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Derived failure modes
-
Unknown
Failed Moisture Limits: Water (moisture) content above the approved product specifications.