Drug product
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 46201 1.
D-1334-2015
Product summary
- Event
- Event 71004
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10,094 vials
- Official record key
drug-enforcement:D-1334-2015
Official wording
Reason: Presence of Particulate Matter
Code information: Lot #: 7801273, 7801284, Exp 05/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter