drugs Class II Updated 2014-10-15

Astellas Pharma US Inc recalls Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx on

Recalled Product

Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01

Hazard / Issue

Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 66482CW, Exp 04/16
View official government recall

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