FDAFDA · Food and drugs·Recall number D-0008-2015
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Published October 15, 2014 · Recall initiated: September 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Astellas Pharma US Inc
- Distributor
- Nationwide
- Lot
- Lot 66482CW, Exp 04/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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