Anticoagulant Inhixa recalled due to typo

The carton used to package two imported batches of anticoagulant Inhixa have the incorrect strength of the product written on one side, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned.

Pharmacists have been told to stop supplying the affected batches of 12,000 IU (120mg)/0.8 ml solution for injection’ Inhixa solution for injection immediately and to contact any patients who have already been dispensed the product to make them aware of the error.

The incorrect strength of the product is written on one side of the carton which states ‘12,000 IU (20mg)/0.8 ml solution for injection’ instead of the correct strength ‘12,000 IU (120mg)/0.8 ml solution for injection’.

Incorrect strength label highlighted on Inhixa. Credit: MHRA

In a medicines recall notification on Thursday, the MHRA said it had been informed by pharmaceutical company Maxearn Limited that approximately 14 defective packs – each containing 10 prefilled syringes – have been released to pharmacies.

All other units from the error batches have been held before onward distribution, the MHRA said.

The remainder of the packaging, including three other sides of the carton, the Patient Information Leaflet (PIL) and the labels on the individual pre-filled syringes all contain the correct strength details, the MHRA said.

The error only affects the ‘parallel imported product repackaged by Maxearn’ and packs from other sources are ‘not affected and should continue to be dispensed’, it added.

And Maxearn is set to arrange for customers to be contacted, including pharmacies, that have received the defective packs.

The affected batch numbers include:

• 0191Y / AG07093D, 10 pack, first distributed on 16/4/2025 and with an expiry date of 31/05/2026
• 9982X / AG11871C, 10 pack, first distributed on 16/4/2025 and with an expiry date of 31/03/2026

Patients have been advised to check the batch number of their pre-filled syringes, (printed on the foil of the individual prefilled syringe label or on the carton) and to contact their pharmacist or GP ‘immediately’ if they have received medicines from one of the error batches.

‘Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy,’ the MHRA added.

‘Patients who are concerned they may have taken an incorrect dose of the medication than what should have been prescribed should seek medical attention.’

Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

There’s further guidance for patients online from the MHRA.

A separate alert issued by the MHRA this week recalled specific batches of Paracetamol 500mg Tablets (Chelonia Healthcare Limited) as a precautionary measure, ‘due to contamination’.