GovWire

DMRC reference number

DMRC-31113538

Company name

Sun Pharma UK Limited

Gemcitabine PPF 1800mg/180ml Infusion bag, PL 31750/0062

SNOMED Code

33492211000001108

Active Pharmaceutical Ingredient: Gemcitabine

Gemcitabine PPF 1600mg/160ml Infusion bag, PL 31750/0062

SNOMED Code

33491811000001100

Active Pharmaceutical Ingredient: Gemcitabine

Irinotecan PPF 360mg/240ml Infusion bag, PL 31750/0159

SNOMED Code

39293911000001107

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 suppliers 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 theMHRA 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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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