Public recall detail

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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Recall Safety notice
Quick summary

Quick summary: 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 .

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: 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 .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand
ProductDIN No.

Issue

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.

Additional official information
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