Drug recall
Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for…
FDA recall event 71004 · Class I · Mylan Institutional LLC
Key facts
| Event ID | 71004 |
|---|---|
| Recall numbers | D-1332-2015, D-1333-2015, D-1334-2015 |
| Recalling firm | Mylan Institutional LLC |
| Product type | Drugs |
| Products | Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457…, Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC…, Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter |
| Initiation date | Mar 23, 2015 |
| Report date | Aug 26, 2015 |
| Termination date | May 20, 2016 |
| City | Rockford |
| State | IL |
| Country | United States |
| FEI number | 3010547225 |
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: