Reported Oct 15, 2014 · Terminated
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc.…
Astellas Pharma US Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Astellas Pharma US Inc · 1 Astellas Way · Northbrook, IL · 60062-6111
Is this the product you have?
- Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only
- Manufactured byKremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
- Lot codes and dates
Lot 66482CWExp 04/16
- Amount recalled
- 9,236 bottles
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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