Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.v., Pemetrexed 1000mg/100ml (10mg/ml) & 800mg/100ml (8mg/ml) Infusion Bag, El(25)a/09

Sun Pharmaceutical Industries Europe B.V. is recalling specific batches of Pemetrexed infusion bags (1000mg and 800mg strengths) distributed in the United Kingdom because testing found particulate matter (solid particles) in the product that exceeded acceptable limits. This is a Class II recall affecting injectable cancer medication batches identified in the official notification.

Recalling firm
Sun Pharmaceutical Industries Europe B.V.
Reason
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.
Classification
Class II
Category
drug recall
Country
United Kingdom
Agency
UK Medicines and Healthcare products Regulatory Agency
Recall date
2025-03-04
Status
Ongoing
Distribution
United Kingdom

Official recall notice from UK Medicines and Healthcare products Regulatory Agency

Recall details on Nibble Recalls: https://trynibble.app/recalls/9afa40d7-82e5-4391-a375-0900f906276d