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 reference number
DMRC-31113538
Company name
Sun Pharma UK Limited
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 |
Active Pharmaceutical Ingredient: Gemcitabine
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 |
Active Pharmaceutical Ingredient: Gemcitabine
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 |
Active Pharmaceutical Ingredient: Irinotecan
Brief description of the 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 for 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 for 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.
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.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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