US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 15, 2014 (12 years ago)

Tarceva

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Astellas Pharma US Inc
NDC code
50242-064-01
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0008-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.