Letters and medicine recalls sent to healthcare professionals in September 2021

A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 6 October 2021

• Therapeutic area: Cancer, Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism and Ophthalmology

Letters

• Bortezomib 2.5mg/ml Solution for Injection (Bortezomib): interim supply of over‐labelled Italian stock to mitigate supply disruption

Medicine Recalls and Notifications

In September 2021, recalls and notifications for medicines were issued on:

Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21). Issued 9 September 2021. Several batches of Rosuvastatin 5mg, 10mg, 20mg and 40mg film-coated tablets have been identified to include older versions of the Patient Information Leaflet in the product packs. The affected batches omit safety warnings on interactions and side effects – full details are available in the medicine notification. There is no risk to product quality as a result of this issue; however, healthcare professionals are advised to exercise caution when dispensing the product and provide an updated Patient Information Leaflet where possible.

Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22. Issued 15 September 2021. Batches of Ikervis 1mg/ml eye drops (ciclosporin) are being recalled after particles or crystals of the active ingredient have been detected during stability testing. No reports of adverse events have been received by the Marketing Authorisation Holder, but there is potential for ocular irritation, eye pain or foreign body sensation due to the presence of particles. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 2 Medicines Recall: Accord-UK Ltd (Trading style: NorthStar), LEVOTHYROXINE TABLETS BP 50 micrograms EL (21)A/23. Issued 27 September 2021. A batch of levothyroxine 50 microgram tablets is being recalled due to variances in tablet hardness identified during stability testing. This is a precautionary recall, as tablets may crumble or break when removed from packaging. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Article citation: Drug Safety Update volume 15, issue 3: October 2021: 5.

Published 6 October 2021