Letters and medicine recalls sent to healthcare professionals in September 2023
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages.
Letters
In September 2023, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In September 2023, recalls and notifications for medicines were issued on:
Class 3 Medicines Recall: Theramex HQ UK Ltd, Evorel Sequi, EL (23)A/34. Issued 5 August 2023. Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. Healthcare professionals are advised to stop supplying the named batches in this alert immediately, quarantine all remaining stock and return it to your supplier using your supplier’s approved process. If a patient presents with the incorrect patches, they should be dispensed a correct pack from another batch. Theramex has confirmed that all other batches are unaffected and that there is no impact on supply.
Class 4 Medicines Defect Information: Colgate-Palmolive (U.K.) Limited, Duraphat 5000ppm Fluoride Toothpaste (51g), EL (23)A/35. Issued 7 August 2023. Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed are missing information relating to the presence of allergens in the product. In addition, the PIL is missing information relating to the concentration of Sodium Benzoate. Healthcare professionals are advised to note the updated information. Where appropriate, inform patients about it, provide them with an updated copy of the PIL, and remind them to read the leaflet in its entirety before using the medicine.
Company led medicines recall: Sun Pharma UK Ltd, Gemcitabine 10mg/ml Solution for Infusion PL 31750/0062 (Single dose Infusion bag, 2000mg/200ml), CLMR(23)A/06. Issued 7 September 2023. Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion. The affected infusion bags are labelled as 1800mg/180ml rather than 2000mg/200ml (though the secondary packaging is labelled correctly as 2000mg/200ml). Healthcare professionals are advised to stop supplying the affected batches immediately. Quarantine all remaining stock and liaise with the manufacturer on the return process.
Class 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36. Issued 20 September 2023. Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. Healthcare professionals are advised to stop supplying the named batches in this alert immediately, quarantine all remaining stock and return it to your supplier using your suppliers approved process.
Class 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules, EL (23)A/37. Issued 27 September 2023. Max Remedies has informed the MHRA that they have identified an infrequent printing error relating to the Braille text printed on the cartons of this product. Some characters may be incorrect leading to potential misinterpretation of the contents/strength of the product. We would advise that blind and/or partially sighted patients are instructed to follow the directions outlined in the PIL as normal and if there are concerns, they should consult with their carer, or alternatively contact Max Remedies. The quality of the capsules is not impacted by this defect and all written information on the packs is correct.
Medical Device Safety Information
We recently published Device Safety Information pages on the following topics:
The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing.
No-React implantable cardiovascular devices already placed on to the UK market remain legally CE marked and available for sale and use. Products already in use or on the UK market are considered safe. This includes devices held in stock by UK distributors and those already sold or supplied to UK healthcare settings. For additional information please refer to the Device Safety Information page.
The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. The device is not designed for feeding.
However, we understand that it has also been used for feeding colostrum to babies.
We are aware of 6 incidents in which the push cap became lodged in the back of the baby’s mouth when it was not removed from the top end of the syringe before being inserted into the baby’s mouth for feeding. There were no fatalities, however one infant required emergency surgery.
The intended use of the device is not for directly feeding the colostrum to babies. The cap must always be removed before use. Healthcare professional advice should be sought for guidance on feeding the collected colostrum to the baby.
The manufacturer is undertaking a design change to minimise the choking hazard associated with the cap. Work is underway on this change and it will take approximately 6 months.
Healthcare professionals are advised to remove the cap before using the device. When instructing parents on using the device, remind them to always remove the cap from the tip of the syringe prior to use. Advise parents on how to feed the collected colostrum to the baby. For additional information, please refer to the Device Safety Information page and press release.
Article citation: Drug Safety Update Volume 17, issue 4: October 2023:4