The company has initiated this recall due to the potential presence of particulate matter in vials from affected lots of Cisplatin Injection, Gemcitabine for Injection and Topotecan for Injection (listed below). Presence of foreign particulate matter in vials of the affected lot could pose the following risks, if injected: local inflammation, phlebitis, allergic response and/or embolization in the body and infection. Investigations related to controls for manufacturing sterile products at the manufacturing site are ongoing.
RecallTracker