Drug recall
GEMZAR (Gemcitabine HCl For Injection),1 g equivalent to base, For I.V. use only, Sterile, Single Use Vial…
FDA recall event 25763 · Class II · Lilly, Eli & Co.
Key facts
| Event ID | 25763 |
|---|---|
| Recall numbers | D-216-3 |
| Recalling firm | Lilly, Eli & Co. |
| Product type | Drugs |
| Products | GEMZAR (Gemcitabine HCl For Injection) ,1 g equivalent to base, For I.V. use only, Sterile, Single Use Vial, Rx only , VIAL No. 7502, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-7502-01 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of assurance of sterility (cracked vials) |
| Initiation date | Mar 19, 2003 |
| City | Indianapolis |
| Country | United States |
| FEI number | 1819470 |
At a glance
- 1–9 Products in this recall
- 10–99 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