Letters and medicine recalls sent to healthcare professionals in January 2022
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
Letters
In January 2022, the following letters were sent or provided to relevant healthcare professionals:
- Ronapreve▼ (casirivimab and imdevimab) 120 mg/ml solution for injection or infusion: Important information for healthcare professionals about the expiry date of the and the
Gina 10 microgram vaginal tablets (estradiol): consultation on proposal to make available from pharmacies
Gina 10 microgram vaginal tablets are a low dose local hormone replacement therapy, authorised for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women. Gina is currently available as a prescription only medicine (POM) and we are considering a proposal to make it available in pharmacies.
The MHRA has launched a public consultation which will be open for comments until midday on 23 February 2022. We are seeking views on reclassifying Gina as a pharmacy medicine and ask healthcare professionals to see the consultation page for more information.
Other medicine recalls and notifications
Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) IKERVIS 1 mg/mL eye drops, emulsion, EL (22)A/01. Issued 19 January 2022. A batch of Ikervis (ciclosporin) 1 mg/mL eye drops emulsion are being recalled as particles or crystals of ciclosporin have been identified during stability monitoring. This is a precautionary recall; the Marketing Authorisation Holder’s investigation has not confirmed that adverse reactions have been caused by the presence of particles. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: Fresenius Kabi Limited, Kabiven Emulsion for Infusion, EL (22)A/02. Issued 25 January 2022. Batches of Kabiven emulsion for infusion, 2053 ml 3-chamber infusion bags have been identified that incorrectly state the amount of glucose monohydrate as 110g. The correct amount of 200g as glucose anhydrous stated on the infusion bag in the energy content section as carbohydrates, on the outer carton and in the Summary of Product Characteristics. Healthcare professionals are advised to exercise caution when administering this product, particularly when calculating patient nutritional requirements.
Class 4 Medicines Defect Information: Antibiotice SA, Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion, EL (22)A/03. Issued 31 January 2022. Batches of Piperacillin 4g and Tazobactam 0.5g powder for solution for infusion have been identified with Patient Information Leaflets that incorrectly state sodium content as 9.39mmol (108mg). The correct sodium content is 9.39mmol (216mg) per product. There are no product quality issues and the batches are not being recalled. Healthcare professionals are advised to calculate sodium content using the correct values when administering this product to patients on sodium restricted diets.
See Alerts, recalls and safety information for all recent notices.
Article citation: Drug Safety Update volume 15, issue 7: February 2022: 5.