Safety alerts
Here you will find key paediatric patient safety alerts.
Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in the SmPC and PIL.
Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.
Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.
Aspar Pharmaceuticals Limited have informed the MHRA of an error related to a batch of Boots Paracetamol 500 mg tablets (16s). The foil blister inside the carton incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. The tablets are confirmed to be Paracetamol 500 mg tablets.
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.
Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compound C impurity during stability testing.
All batches of the named products are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the incorrect grade of an excipient.
Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro-resistant capsule, hard”.
Full information can be found on the MHRA website here.
CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets.
Bristol Laboratories Limited is recalling the batches specified in the table as a precautionary measure due to possible microbial contamination.
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safety information.
The Royal College of Emergency Medicine (RCEM) has issued safety flashes regarding the dangers of ingested or inhaled magnets, water beads, and button/coin cell batteries. These items, often found in children’s toys, pose significant risks.
- Strong Magnets: Found in desk toys and fake piercings, these can cause intestinal injury within hours of ingestion, though symptoms may be delayed.
- Water Beads: Used in toys, stress balls, and vase fillers, these expand dramatically when exposed to liquid, posing a risk of obstruction if ingested or inhaled.
- Button/Coin Cell Batteries: Ingestion or inhalation can lead to serious harm or death due to chemical tissue erosion.
Key Recommendations for Clinicians:
- For young children and individuals with learning disabilities presenting with unexplained gastrointestinal or respiratory symptoms, inquire about potential access to these items, not just observed ingestion/inhalation.
- If the ingested/inhaled object is unknown and there is a possibility of battery, magnet, or sharp object ingestion, X-rays are indicated (water beads are radiolucent).
- Symptomatic patients who have ingested strong magnets require urgent surgical review.
For more details please see the RCEM Safety Flashes
A National Patient Safety Alert was issued by the NHS England National Patient Safety team, endorsed by the Royal College of Obstetricians and Gynaecologists, Royal College of Midwives and Royal College of Anaesthetists, in September 2024. This warns of the risk of oxytocin overdose if postpartum infusions are mistakenly given during labour which can lead to dangerous complications such as placental abruption and fetal distress.
Key actions for healthcare professionals include ensuring oxytocin infusions are not pre-prepared at ward level and that postpartum kits are readily available.
Full details and required actions (by 31 March 2025) on NHS England website
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals should advise patients and their caregivers to be alert to these risks and seek medical advice as soon as possible if neuropsychiatric reactions occur.
The FSA has issued new voluntary industry guidance on glycerol in slush-ice drinks, advising that they should not be sold to children four years of age and under.
At very high levels of exposure – typically when several of these products are drunk by a child in a short space of time – glycerol intoxication could cause shock, hypoglycaemia and loss of consciousness.
See the FSA for further details
Considerations:
- Is glycerol exposure in healthcare professionals differential diagnoses when reviewing a hypoglycaemic child?
- Do hospital shops sell slushies? Are parents aware of the risks?