Astellas Pharma US Inc recalls Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seym
Recalled October 15, 2014 · FDA recall D-0008-2015 · Astellas Pharma US
Hazard
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing. · FDA Class II
Units
9,236 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Product
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Manufacturer(s)
Astellas Pharma US Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →