Letters and medicine recalls sent to healthcare professionals in May 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices
Letters
In May 2022, the following letters were sent or provided to relevant healthcare professionals:
- . See accompanying medicine recall below for more information.
- . See accompanying medicine notification below for more information
- Important shelf-life update for COMIRNATY ▼10 micrograms/dose concentrate for dispersion for injection (tozinameran), COVID-19 mRNA Vaccine (nucleoside-modified) for children 5 to 11 years - and
Medicine Recalls and Notifications
In May 2022, recalls and notifications for medicines were issued on:
Class 2 Medicines Recall: Pfizer Limited, Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets, EL(22)A/21. Issued 5 May 2022. As noted in the May 2022 Drug Safety Update, Pfizer Ltd are voluntarily recalling all stock of Accupro (quinapril hydrochloride) film-coated tablets as a precautionary measure due to the identification of a nitrosamine above the acceptable limit. Based on the available data, there is no immediate risk to patients who have been taking this medication. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier. Healthcare professionals should advise patients not to discontinue Accupro without consulting their prescriber as there are potential risks associated with suddenly stopping treatment for blood pressure. A letter was sent to prescribers in May 2022.
Class 2 Medicines Recall: Quadrant Pharmaceuticals Ltd, Mefenamic Acid 500mg film coated tablets, EL (22)A/23. Issued 17 May 2022. A batch of mefenamic acid 500mg film coated tablets is being recalled due to some tablets possessing a defective film coating resulting in the tablet core being partially exposed. This is a precautionary recall and the Marketing Authorisation Holder had not received any reports of adverse reactions related to the issue Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: GlaxoSmithKline UK Ltd, Zovirax I.V. 500 mg, EL (22)A/22. Issued 9 May 2022. Batches of Zovirax intravenous (I.V.) 500mg have been identified to contain an incorrect version of the Summary of Product Characteristics and Patient Information Leaflet. These incorrect versions contain unapproved text on dosage for obese adults and on dosage adjustments in renal impairment for infants and children. Healthcare professionals prescribing and administering this product should refer to the corrected and approved Package Leaflet and discard the incorrect version inside the sealed packs. A letter was sent to prescribers in May 2022.
Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A/24. Issued 25 May 2022. Batches of water for injections BP 100ml vial are being recalled. This is a precaution as vials may no longer be in line with licensed product specification regarding pH and conductivity. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: Orifarm UK Ltd, Loprazolam 1mg Tablets, EL (22)A/25. Issued 26 May 2022. Batches of Loprazolam (loprazolam mesylate) 1mg tablets have been identified to contain Patient Information Leaflets where the title incorrectly states the product name as ‘lorazolam’. Healthcare professionals are advised to inform patients of this discrepancy when dispensing packs from this batch.
Company led medicines recall: Consilient Health UK Ltd, Invita D3 800 IU Soft Capsules, CLMR (22)A/03. Issued 30 May 2022. A batch of Invita D3 800 IU (cholecalciferol) soft capsules is being recalled by the company as limited number of units were distributed prior to batch release. There are no indications of any quality of safety concerns and this recall is precautionary due to the regulatory non-compliance. Stop supplying the batch immediately, quarantine all remaining stock and return to the company.
Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion, EL (22)A/26. Issued 31 May 2022. A batch of Esomeprazole 40mg Powder for Solution for Injection or Infusion has been identified with an incorrect Global Trade Item Number (GTIN). The incorrect GTIN on the batch is 05026468771424 which scans as acetylcysteine 200mg/ml injection (2g/10ml ampoules). Healthcare professionals should not use the GTIN barcode for any dispensing activities for the affected batch.
Medical Device Safety Information
A recent MHRA National Patient Safety Alert has been published on:
National Patient Safety Alert: NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis (NatPSA/2022/004/MHRA). Issued 26 May 2022. See the article in this issue of Drug Safety Update.
For all of the latest safety notices from the MHRA on drugs and medical devices, see Alerts and recalls for drugs and medical devices.
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Article citation: Drug Safety Update volume 15, issue 11: June 2022: 4.