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 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.
DMRC reference number
DMRC-34805959
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Medicine Details
Pemetrexed SUN 10 mg/ml solution for infusion (Infusion bag)
Licence: PL 31750/0193
Active ingredient: Pemetrexed disodium heptahydrate
SNOMED code: 41445711000001105
GTIN: 8719323332256
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| HAF1473A | 31/05/2026 | 1 | 02/10/2024 |
Medicine Details
Pemetrexed SUN 8 mg/ml solution for infusion (Infusion bag)
Licence: PL 31750/0190
Active ingredient: Pemetrexed disodium heptahydrate
SNOMED code: 41445111000001109
GTIN: 8719323332195
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| HAF0544A | 28/02/2026 | 1 | 20/05/2024 |
Background
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.
Advice for Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s 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 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.
Additional information:
For stock control enquiries please contact Customer Service UK Cserv.uk@sunpharma.com or phone (0) 20 8848 5050
Recipients of this Medicines Notification 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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