Pedmarqsi 80 mg/mL solution for infusion
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 2 recall · DMRC - 41054154
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Pedmarqsi 80 mg/mL solution for infusion | PLGB: 20011/0078 | sodium thiosulfate | 5012748616745 |
Batches (expiry): 458273 (12/2026), 475287 (12/2026)
Background: Norgine Pharmaceuticals Limited is recalling the batches listed in the table due to risk of particulate matter being present in the product identified during routine stability investigations. No adverse reactions related to this issue have been reported by users. Norgine Pharmaceuticals Limited has confirmed that the issue is currently limited to the two batches in this recall. However, investigations concerning all other batches are ongoing. Advice for Healthcare Professionals: