FDA-Drug2014-10-15Class II
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Astellas Pharma US Inc
Hazard
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Sold states
Nationwide
Affected count
9,236 bottles
Manufactured in
1 Astellas Way, Northbrook, IL, United States
Products
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2015Don't want to check this manually?
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