FDA recall D-0008-2015

Astellas Pharma US Inc · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-09-15
Report date: 2014-10-15
Termination date: 2015-05-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2015