Recalls / Class II
Class IID-0008-2015
Product
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
- Affected lot / code info
- Lot 66482CW, Exp 04/16
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.
Recalling firm
- Firm
- Astellas Pharma US Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Astellas Way, Northbrook, Illinois 60062-6111
Distribution
- Quantity
- 9,236 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-15
- FDA classified
- 2014-10-07
- Posted by FDA
- 2014-10-15
- Terminated
- 2015-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0008-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.