D-0913-2023 Class II Terminated
FDA drug recall D-0913-2023 was initiated by Teva Pharmaceuticals USA Inc on July 5, 2023 and is designated Class II. Reason for recall: Failed Moisture Limits: Water (moisture) content above the approved product specifications. The recall status is terminated (terminated January 10, 2024). Affected quantity: 180 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2023
- Initiation Date
- July 5, 2023
- Termination Date
- January 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 bottles
Product Description
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.
Distribution Pattern
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Code Information
Lot # 100037220, Exp 10/2024