Drug recall
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals…
FDA recall event 69246 · Class II · Astellas Pharma US Inc
Key facts
| Event ID | 69246 |
|---|---|
| Recall numbers | D-0008-2015 |
| Recalling firm | Astellas Pharma US Inc |
| Product type | Drugs |
| Products | Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Sep 15, 2014 |
| Report date | Oct 15, 2014 |
| Termination date | May 19, 2015 |
| City | Northbrook |
| State | IL |
| Country | United States |
| FEI number | 1000036852 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: