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
D-0008-2015
Product summary
- Event
- Event 69246
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,236 bottles
- Official record key
drug-enforcement:D-0008-2015
Official wording
Reason: Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Code information: Lot 66482CW, Exp 04/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications