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Class 2 Medicines Recall: Sun Pharma UK Limited, Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion Bag, EL(24)A/29

Medicines Healthcare Products Regulatory Agency

July 16
10:07 2024

DMRC reference number

DMRC - 31045928

Company name

Sun Pharma UK Limited

Pemetrexed 1000MG/100ML (10mg/ml) Infusion Bag, PL 31750/0193

SNOMED Code

41445611000001101

Batch Number Expiry Date Pack Size First Distributed
HAF0083A 31 December 2025 1 18 March 2024

Active Pharmaceutical Ingredient: pemetrexed

Pemetrexed 1100MG/100ML (11mg/ml) Infusion Bag, PL 31750/0194

SNOMED Code

41445911000001107

Batch Number Expiry Date Pack Size First Distributed
HAE0425A 31 July 2025 1 2 November 2023

Active Pharmaceutical Ingredient: pemetrexed

Brief description of the problem

Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.

Advice for healthcare professionals

Stop supplying the listed batches immediately. Quarantine all remaining stock and return it to your supplier using your suppliers 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 for 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 should continue to take medicines as prescribed 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, 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

DMRC@mhra.gov.uk

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Class 2 Medicines Recall: Sun Pharma UK Limited, Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion Bag, EL(24)A/29

Updates to this page

Published 16 July 2024

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