Cisplatin Injection 1 mg/mL, Gemcitabine for Injection, USP 1g and 2… — recall 53367
Health Canada — Marketed Health Products · Canada · 2015-03-14
As described by Health Canada — Marketed Health Products: Cisplatin Injection 1 mg/mL, Gemcitabine for Injection, USP 1g and 2 g per vial, and Topotecan HCl for Injection 4 mg per vial - Recall of Lots Which May Contain Foreign Particulate Matter
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Archived by the issuing authority — kept for reference
Reported risk: 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.
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