Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

FDA recall notice · announced July 19, 2023 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Notes

Distribution: Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Lot/code information: Lot # 100037220, Exp 10/2024
Quantity: 180 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.