D-0008-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2014
- Initiation Date
- September 15, 2014
- Termination Date
- May 19, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,236 bottles
Product Description
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 Pattern
Nationwide
Code Information
Lot 66482CW, Exp 04/16