Recalls / Class II
Class IID-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
- Brand name
- Sunitinib Malate
- Generic name
- Sunitinib Malate
- Active ingredient
- Sunitinib Malate
- Route
- Oral
- NDCs
- 0093-8199, 0093-8224, 0093-8229, 0093-8231
- FDA application
- ANDA213803
- Affected lot / code info
- Lot # 100037220, Exp 10/2024
Why it was recalled
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 180 bottles
- Distribution pattern
- Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Timeline
- Recall initiated
- 2023-07-05
- FDA classified
- 2023-07-11
- Posted by FDA
- 2023-07-19
- Terminated
- 2024-01-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0913-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.