Letters and drug alerts sent to healthcare professionals in July 2019

Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium). A recall was issued for several medicines taken out of the regulated medicines supply chain, including a patient-level recall for Neupro 4mg/24hr patches and Vimpat 100mg tablets.


The following letters were sent to healthcare professionals in July 2019:

Recall alerts for medicines taken out of the supply chain during distribution

Following the issue of FMD Alert EL (19)A/15 on 27 June 2019, MHRA has become aware of further affected products that were imported into the UK from Italy and re-labelled in Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd livery.

A new recall alert was issued on 25 July 2019 – FMD Alert: Class 2 (EL (19)A/19).

Products being recalled at patient level are:

  • Neupro 4mg/24hr patches
  • Vimpat 100mg tablets

If patients have any of these affected products, they are advised to continue taking their medicines and contacting their prescriber to arrange a new prescription. Patients should return the affected batches to their pharmacist once they have a new prescription.

The products being recalled at pharmacy level are:

  • Dovobet gel
  • DuoResp Spiromax 160mcg / 4.5mcg inhaler
  • Incruse Ellipta 55mcg Inhaler
  • Seretide Evohaler 250mcg
  • Spiriva 18mcg inhalation powder capsules

Patients with the products being recalled at pharmacy level should continue taking their medicines. They do not need to arrange a new prescription but are advised to speak to a healthcare professional if they have any questions.

Other alerts

Class 2 Medicines Recall: Bisacodyl 5mg Gastro-Resistant tablets batch 25074A (MDR 34-04/19). Issued 24 July 2019. The listed batch has been recalled because a small number of packs have been found to contain tablets which are stuck together, with mould observed on some tablets. It is unlikely that affected tablets will have got to patient level as the sticking is noticeable on opening the pack, nevertheless, batch 25074A should be quarantined and returned to the supplier.

Class 2 Medicines Recall: Aripiprazole 1mg/ml oral solution (EL (19)A/20). Issued 30 July 2019. Listed batches have been recalled due to the potential for small particles of Aripiprazole active material to be present, which could affect the efficacy of the product. No relevant product complaints or adverse reaction reports have been received by the company from the UK market to date.

Class 4 Medicines Defect Information: Phenobarbital Sodium 30mg/ml Injection (MDR 48-02/19). Issued 8 July 2019. The EAN bar code for the listed batches is incorrect, which increases the risk of medication error due to product mix-up when an automated inventory system is used to dispense the affected batch within the pharmacy or wholesale facility. The barcode should not be used for any dispensing activities for the listed batches.

Healthcare professionals are also reminded of the caution in use notice issued for Emerade adrenaline autoinjectors. Prescribers and dispensers should inform patients of the very rare risk of the product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle. Healthcare professionals should continue to reinforce that patients should always carry TWO in-date adrenaline auto-injectors with them. For more information, see July 2019 Drug Safety Update.

Article citation: Drug Safety Update volume 13, issue 1: August 2019: 4.

Published 19 August 2019