Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V. EL(25)A/09
Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/ML (8mg/ml) Infusion bag, EL(25)A/09
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.
DMRC Number: DMRC-34805959
Company name: Sun Pharmaceutical Industries Europe B.V.
Product descriptions:
Pemetrexed SUN 10 mg/ml solution for infusion (Infusion bag) - Licence: PL 31750/0193, SNOMED code: 41445711000001105, GTIN: 8719323332256
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| HAF1473A | 31/05/2026 | 1 | 02/10/2024 |
Pemetrexed SUN 8 mg/ml solution for infusion (Infusion bag)- Licence: PL 31750/0190, SNOMED code: 41445111000001109, GTIN: 8719323332195
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| HAF0544A | 28/02/2026 | 1 | 20/05/2024 |
Brief description of problem:
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 to 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.
Advice to Patients:
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients do not have direct contact with this type of medicine as it must be administered by a healthcare professional. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For stock control enquiries please contact Customer Service UK Cserv.uk@sunpharma.com or phone (0) 20 8848 5050
To access the full recall: Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/ML (8mg/ml) Infusion bag, EL(25)A/09