Letters and medicine recalls sent to healthcare professionals in July 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
Letters
In July 2021, the following letters were sent or provided to relevant healthcare professionals:
Desogestrel-containing contraceptive pills: reclassification decisions by the MHRA
In July 2021, the MHRA agreed to reclassify 2 desogestrel-containing progestogen-only oral contraceptives (Hana 75 microgram, Lovima 75 microgram) from prescription-only (POM) to pharmacy (P) products for the prevention of pregnancy in women of childbearing age. The MHRA’s decision to reclassify these desogestrel products follows a safety review by the Commission on Human Medicines (CHM) and public consultation. See Hana public assessment report and Lovima public assessment report.
Medicine Recalls and Notifications
In July 2021, recalls and notifications for medicines were issued on:
Class 2 Medicines Recall: Kyowa Kirin Limited, Xomolix 2.5 mg/ml solution for injection, EL (21)A/15. Issued 1 July 2021. Two batches of Xomolix (droperidol) 2.5mg/ml solution for injection are being recalled as a precautionary measure due to reports of contamination with glass and cellulose fibres. This particulate contamination could potentially induce local inflammatory responses or lead to embolisation in small capillaries. Stop supplying the batches immediately, quarantine all remaining stock and return to supplier. Where possible, patients who have been recently administered a product from an affected batch should be monitored closely.
Company led medicines recall: Morphine Syringe 50mg/50ml (unlicensed medicine) and Magnesium Sulphate 8mmol/20ml infusion (unlicensed medicine). Issued 1 July 2021. A batch of each of the unlicensed medicines morphine syringe 50mg/50ml and magnesium sulphate 8mmol/20ml infusion are being recalled by the company. This is a precautionary recall as batches have been identified to be potentially contaminated. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information, Tetralysal 300mg Hard Capsules, (PL 10590/0019), EL (21)A/16. Issued 6 July 2021. Several batches of Tetralysal (lymecycline) 300mg Hard Capsules have been identified to include older versions of the Patient Information Leaflet in the product packs. The affected batches omit safety warnings on precautions, medicine 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 4 Medicines Defect Information, Sevredol 10 mg and 20mg tablets, (PL 16950/0063, PL 16950/0064), EL (21)A/17. Issued 12 July 2021. Several batches of Sevredol (morphine sulfate) 10mg and 20mg tablets have been identified to include older versions of the Patient Information Leaflet. The patient information in the affected batches omits safety warnings on precautions, interactions and possible 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 4 Medicines Defect Information, Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248), EL (21)A/18. Issued 19 July 2021. Batches of Amoxicillin 500mg/5ml Powder for oral suspension have been identified that state an incorrect amount of the excipient sodium benzoate. There is no risk to product quality as a result of this issue and thus the product is not being recalled. Healthcare professionals are asked to make colleagues in clinics, GP surgeries, and community pharmacies aware for information.
For all of the latest safety notices from the MHRA on drugs and medical devices, including a recent recall of irbesartan-containing products issued in August 2021, see Alerts and recalls for drugs and medical devices.
Article citation: Drug Safety Update volume 15 issue 1: August 2021: 2.
Post-publication note:
The letter about Hemabate Sterile Solution was updated in August 2021 to reflect an updated version of the letter (dated 18 August). The change in this version was to provide an updated link to the US Prescribing Information on page 3.