Why it was recalled
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
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
Lot numbers, UPCs & expiration codes
Lot # 100037220, Exp 10/2024
Where it was sold
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0913-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 5, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 180 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0913-2023, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92636
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot # 100037220, Exp 10/2024
- Postal code
- 07054-1120
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0913-2023
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 180 bottles
- Termination date
- Jan 10, 2024
- Reason for recall
- Failed Moisture Limits: Water (moisture) content above the approved product specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
- Recall initiation date
- Jul 5, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2023