Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Reported: October 15, 2014 Initiated: September 15, 2014 #D-0008-2015
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.
Details
- Recalling Firm
- Astellas Pharma US Inc
- Units Affected
- 9,236 bottles
- Distribution
- Nationwide
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01. Recalled by Astellas Pharma US Inc. Units affected: 9,236 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 15, 2014. Severity: Moderate. Recall number: D-0008-2015.
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