Pemetrexed SUN 10 mg/ml solution for infusion (Infusion bag)
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-34805959
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Pemetrexed SUN 10 mg/ml solution for infusion (Infusion bag) | PL 31750/0193 | Pemetrexed disodium heptahydrate | 8719323332256 |
| Pemetrexed SUN 8 mg/ml solution for infusion (Infusion bag) | PL 31750/0190 | Pemetrexed disodium heptahydrate | 8719323332195 |
Batches (expiry): HAF1473A (31/05/2026), HAF0544A (28/02/2026)
Background: Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during stability testing. Advice for Healthcare Professionals: Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process. This medicine is being recalled as a precautionary measure and should present no direct harm to patients who have already received these batches.