FDA-Drug2023-07-19Class II
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Teva Pharmaceuticals USA Inc
Hazard
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Sold states
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Affected count
180 bottles
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0913-2023Don't want to check this manually?
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