Letters and medicine recalls sent to healthcare professionals in March 2023
A summary of recent letters and notifications sent to healthcare professionals about medicines.
Letters
In March 2023, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In March 2023, recalls and notifications for medicines were issued on:
Class 2 Medicines Recall: Teva UK Limited, Levothyroxine 12.5mcg Tablets, EL (23)A/06. Issued 2 March 2023. Teva UK Limited is recalling one batch of Levothyroxine 12.5mcg Tablets in response to a lower than required assay result discovered during routine stability testing. Healthcare professionals should stop supplying the affected batch immediately, quarantine all remaining stock and return it to the supplier.
Class 4 Medicines Defect Information: Thornton & Ross Ltd, Methadone 1mg/mL Oral Solution BP - Sugar Free, Methadone Mixture 1mg/ml, EL(23)A/07. Issued 7 March 2023. Specific batches of Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml, have been packaged with the incorrect Product Information Leaflet (PIL). Links to the correct PILs are provided in the notice.
Class 4 Medicines Defect Information: Drugsrus Limited, Clexane 10,000 IU (100mg) / 1ml Syringes, EL(23)A/08. Issued 9 March 2023. The Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical error. The strength of the product listed in the leaflet header states “100,000 IU (100mg) / 1ml” instead of “10,000 IU (100mg)/1ml”. The remainder of the packaging states the correct strength of 10,000 IU (100mg)/1ml. There is no risk to product quality. Healthcare professionals are advised to tell patients about the error and reassure them that they have the right dose of medicine.
Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09. Issued 14 March 2023. Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution. Healthcare professionals should stop supplying the products listed in this recall immediately. Quarantine all remaining stock and return it to your supplier. Healthcare professionals should recommend appropriate treatment alternatives. Where appropriate, healthcare professionals should also check whether patients who are scheduled to undergo general anaesthesia with neuromuscular blocking agents (NMBAs) have used pholcodine, particularly in the previous 12 months, and remain vigilant for the risk of anaphylaxis in these patients. Patients should be advised to tell their anaesthetist if they think they have previously taken pholcodine.
Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 150mg, 225mg, 300mg prolonged-release tablets, EL(23)A/10. Issued 16 March 2023. In addition to the batches included in the previous Class 4 Medicines Notification (reference EL(22)A/47), Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the branded version of the product (Venlalic® XL prolonged-release tablets). It should instead reflect the generic name: Venlafaxine XL prolonged-release tablets. The code under the pre-printed barcode is correct. There is no risk to product quality as a result of this issue. Healthcare professionals are advised to exercise caution when dispensing the products.
Class 3 Medicines Recall: Rosemont Pharmaceuticals Limited, Sildenafil 10mg/ml Oral Suspension, EL(23)A/11. Issued 21 March 2023. The Press In Bottle Adaptor (PIBA) supplied with the pack (carton) of a specific batch is too wide to fit the neck of the medicine bottle. Healthcare professionals should stop supplying the affected batch immediately, quarantine all remaining stock and return it to the supplier. There is no risk to product quality.
Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, GONAPEPTYL Depot 3.75mg, Powder and solvent for suspension for injection, EL(23)A/12. Issued 23 March 2023. Ferring Pharmaceuticals Limited is recalling certain batches of GONAPEPTYL Depot 3.75mg due to a defect identified in the seal of the needle wrapping for the CE-marked 30-millimeter (30mm) needle for subcutaneous injection that is supplied with each product pack. Slight damage was detected in some sterile needle blisters, which renders the sealing to be incomplete. There is no quality issue with the drug product. Healthcare professionals should stop supplying the affected batches immediately, quarantine all remaining stock and return it to the supplier.
Class 4 Medicines Defect Information: Ethigen Limited, Briviact 75mg & 100mg film-coated tablets, EL(23)A/13. Issued 30 March 2023. The Patient Information Leaflet (PIL) in Briviact 75mg and Briviact 100mg film coated tablets contains incorrect or missing information due to a formatting error. There is no risk to product quality as a result of this issue. Healthcare professionals are advised to exercise caution when dispensing the affected batches of the product. Where possible, please provide an updated copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine.
Medical Device Safety Information
We recently published a Device Safety Information page on the following topic:
This Device Safety Information replaces advice in DSI/2023/002, which should no longer be followed. The manufacturer (Carnamedica) has identified a number of issues with their third-party suppliers of Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution. Concerns have been raised about the aseptic filling process, leak testing of the bags and the conditions under which filled bags are stored and transported.
The latest advice includes an updated list of LOTs associated with defect reports, additional problems identified with the solution, and new actions for healthcare professionals. The MHRA continues to work with Carnamedica and Bridge to Life (UK Responsible Person) and may provide further updates as new information is identified.
Belzer UW Cold Storage Solution (CSS) is intended for flushing and cold storage of kidney, liver and pancreas organs at the time of their removal from the organ donor in preparation for storage, transportation and eventual transplantation into a donor recipient.
Belzer UW Machine Perfusion Solution (MPS) is intended for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys.
Bridge to Life issued an updated Field Safety Notice dated 1 March 2023, broadening the scope of the corrective action.
The list of problems identified to date is:
- microbiological contamination
- particulate matter within the solution
- leakage of fluid
- growth of black mould on the exterior of the connectors
An investigation is ongoing into the root cause of the problems identified and, therefore, unlisted LOT numbers are not guaranteed to be unaffected by these issues. LOT numbers involved in confirmed reports are provided in the Devices Safety Information page to support stakeholders in providing increased vigilance to patients who have received organs where affected lots were used.
Article citation: Drug Safety Update volume 16, issue 9: April 2023: 4.