FDARecalled Jul 19, 2023 · #D-0913-2023
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Hazard
Class II — temporary health risk
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Failed Moisture Limits: Water (moisture) content above the approved product specifications. Classification: Class II Distribution: Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Model numbers
- 100037220
- UPCs
- —