Letters and medicine recalls sent to healthcare professionals in August 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines
Letters
In August 2022, the following letters were sent or provided to relevant healthcare professionals:
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- see accompanying Drug Safety Update article
- Comirnaty ▼30 micrograms/dose concentrate for dispersion for injection (tozinameran), COVID-19 mRNA Vaccine (nucleoside modified): important shelf-life update for and
Medicine Recalls and Notifications
In August 2022, recalls and notifications for medicines were issued on:
National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRA. Issued 4 August 2022. Batches of mexiletine hydrochloride 50mg, 100mg and 200mg hard capsules are being recalled due to a due to a potential risk of underdose or overdose that could have consequences for the safety of patients. Please see the national patient safety alert notice for more information and actions to take.
Company led medicines recall: Stockport Pharmaceuticals, Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine), CLMR (22)A/06. Issued 8 August 2022. A batch of Sodium Chloride Eye Drops 5% w/v 1x10ml (unlicensed medicine) is being recalled as the sterile eye droppers supplied with this product are expired. Stop supplying the batch immediately, quarantine all remaining stock and return to the company.
Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe BV, Zoledronic acid SUN 5mg solution for infusion, EL(22)A/34. Issued 11 August 2022. Batches of Zoledronic acid SUN 5mg solution for infusion are being recalled as a precaution due to out of specification results observed for Particulate Matter Test during routine stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg and 20 mg film-coated tablets EL (22)A/35. Issued 17 August 2022. Further batches of Rosuvastatin 5mg, 10mg and 20mg film-coated tablets have been identified to contain Patient Information Leaflets omitting the latest safety information on medicine interactions and possible side effects. Healthcare professionals are advised to exercise caution when dispensing the product and asked to provide an updated Patient Information Leaflet where possible.
Class 2 Medicines Recall: Dysport 500 Units Powder for Solution for Injection, EL(22)A/36. Issued 22 August 2022. A batch of Dysport (clostridium botulinum type A toxin-haemagglutinin complex) 500 Units Powder for Solution for Injection has been identified as a falsified medicine and is being recalled. Stop supplying the above falsified batch immediately, quarantine all remaining stock and return it to your supplier for onward investigation.
Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines) EL(22)A/37. Issued 30 August 2022. Batches of Lorazepam 2mg/ml and 4mg/ml Injection (unlicensed medicine) are being recalled due to an out of specification result with related substances during testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Clinical Practice Research Datalink studies: DaRe2THINK and ASMPTOMATIC trials for GP practices
Clinical Practice Research Datalink (CPRD, part of the MHRA) is a real-world research service to support public health and clinical research projects. CPRD collects anonymised patient data to inform clinical guidance and best practice. All GP practices across the UK that use EMIS, SystmOne, and Vision clinical IT systems are encouraged to sign up to CPRD for free practice-level quality improvement reports and to take part in optional research studies.
CPRD is currently recruiting GP practices using EMIS IT systems to take part in 2 trials to benefit patients:
- The DaRe2THINK trial is investigating if early intervention with direct oral anticoagulants can reduce the risk of cognitive decline and vascular dementia in patients with atrial fibrillation
- The ASYMPTOMATIC trial is aiming to find the best treatment for children with mild asthma by investigating whether only using a preventer inhaler when a child has asthma symptoms is as effective as using a preventer inhaler every day.
For more information and to sign up, please see the CPRD webpage or contact GPnetwork@mhra.gov.uk
Article citation: Drug Safety Update volume 16, issue 2: September 2022: 4.