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.
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
Lot numbers, UPCs & expiration codes
Lot 66482CW, Exp 04/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0008-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 15, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 9,236 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Astellas Pharma US Inc
Original FDA data
Every field from FDA enforcement report D-0008-2015, exactly as published.
Show all FDA fields
- City
- Northbrook
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69246
- Address
- 1 Astellas Way
- Code information
- Lot 66482CW, Exp 04/16
- Postal code
- 60062-6111
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0008-2015
- Classification
- Class II
- Recalling firm
- Astellas Pharma US Inc
- Product quantity
- 9,236 bottles
- Termination date
- May 19, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 15, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 7, 2014