Class 2 Medicines Recall: Sun Pharma UK Limited
Class 2 Medicines Recall: Sun Pharma UK Limited, Gemcitabine PPF 1800mg/180mL Infusion; Gemcitabine PPF 1600mg/160mL Infusion; Irinotecan PPF 360mg/240mL Infusion, EL(24)A/28
Sun Pharma UK Ltd is recalling certain batches as a precautionary measure due to a small number of leaks found intermittently in the infusion bags.
DMRC Number: DMRC-31113538
Company name: Sun Pharma UK Limited
Product descriptions:
Gemcitabine PPF 1800mg/180ml Infusion bag, PL 31750/0062
SNOMED Code: 33492211000001108
| Batch Number | Expiry Date | Pack Size | First Distributed |
| HAD3634A | 30.09.2024 | 1 | 21.02.2023 |
Gemcitabine PPF 1600mg/160ml Infusion bag, PL 31750/0062
SNOMED Code: 33491811000001100
| Batch Number | Expiry Date | Pack Size | First Distributed |
| HAE1532A | 30.06.2025 | 1 | 20.12.2023 |
Irinotecan PPF 360mg/240ml Infusion bag, PL 31750/0159
SNOMED Code: 39293911000001107
| Batch Number | Expiry Date | Pack Size | First Distributed |
| HAE1191A | 30.06.2025 | 1 | 20.12.2023 |
Brief description of problem:
Sun Pharma UK Ltd is recalling the above batches as a precautionary measure due to a small number of leaks found intermittently in the infusion bags.
Advice to Healthcare Professionals:
Use precaution when handling these products, ensure that the appropriate personal protective equipment is used. Stop supplying the above batches immediately. Quarantine all remaining stock in sealed containers and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines provided by your 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 medical information enquiries please contact, medinfoeurope@sunpharma.com.
For stock control enquiries please contact Sun Pharma Customer Service, Cserv.uk@sunpharma.com.
To access the full recall: