Letters and medicine recalls sent to healthcare professionals in February 2022
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
Letters
In February 2022, the following letters were sent or provided to relevant healthcare professionals:
- . See accompanying Drug Safety Update article
Medicine Recalls and Notifications
In February 2022, recalls and notifications for medicines were issued on:
Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, EL (22)A/04. Issued 1 February 2022. A batch of ibuprofen 400mg tablets has been identified that has some cartons with illegible embossed batch numbers. This poses a risk to traceability in the event of a future recall. The batch number on the tablet blisters is clear and there is no issue with product quality. Healthcare professionals should check the blisters before dispensing the affected batch to ensure the batch number can be read.
Company led medicines recall: Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine), CLMR (22)A/01. Issued 14 February 2022. A batch of Bucain Hyperbar (bupivacaine hydrochloride) 5mg/ml Solution for Injection is being recalled by the company. This is a precautionary recall due to out of specification pH results identified during stability testing. This is an unlicensed medicine that is only supplied to hospital pharmacies. Stop supplying the batch immediately, quarantine all remaining stock and return to the UK importer.
Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06. Issued 15 February 2022. A batch of Water for Injections 100ml vial is being recalled as a precautionary measure due to out of specification results for pH and conductivity during stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 2 Medicines Recall: Uni Health Distribution, Efudix 5% w/w cream, EL (22)A 07. Issued 17 February 2022. A batch of Efudix (fluorouracil) 5% w/w cream is being recalled from pharmacies as a precautionary measure as cartons may contain Patient Information Leaflets for a different medicine. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier. Healthcare professionals are asked to share an appropriate leaflet with the patient where possible.
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial), EL (22)A 08. Issued 17 February 2022. Batches of Fluorouracil Injection (5-fluorouracil) 50 mg/ml, solution for injection are being recalled as a precautionary measure due to the presence of glass lamellae particles identified during stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
UPDATE: Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09. Issued 23 February 2022. This is an update of the Class 4 Medicines defect information issued on 3 February 2022. Batches of Naprosyn (naproxen) 250mg and 500mg tablets, and Naprosyn (naproxen) EC 250mg and 500mg Gastro-Resistant tablets have been identified to contain Patient Information Leaflets that omit medicine interactions wording for naproxen with aspirin (acetylsalicylic acid). Healthcare professionals dispensing any of the affected batches are asked to provide an updated Patient Information Leaflet. Healthcare professionals should also remind patients to seek medical advice if taking aspirin (acetylsalicylic acid) with Naprosyn Tablets or Naprosyn EC Gastro-Resistant Tablets due to the increased risk of bleeding when these medicines are taken concurrently.
Medical Device Safety Information
In February 2022, MHRA Device Safety Information pages have been published on:
Surdial X Haemodialysis machine: potential for devices to remove excess fluid outside of machine specification. DSI/2022/002. Issued 17 February 2022. The MHRA is aware of instances of Surdial X haemodialysis machines removing excess fluid via ultrafiltration outside of its specification. There is a small risk of dialysis-induced hypotension in patients who are unable to tolerate excess fluid removal, including patients with poor cardiac function, sepsis, and diabetes with autonomic neuropathy. The manufacturer issued a Field Safety Notice in July 2021 and is continuing to investigate this matter. Actions for heads of renal units, renal nurses, and renal technicians are available in the device safety information.
Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK: all lots and batches. DSI/2022/001. Issued 17 February 2022. The MHRA has become aware that the Insulated Medium Cusco Speculum with smoke tubes and gynaecological hysteroscopy sheaths from Gemini Surgical UK or Gemini Medical Innovations are being sold with a falsely applied CE mark. This means that these devices have been sold without evidence of safety and have been manufactured to unknown standards. Stop using these devices and use a suitable alternative. Actions for the Patient Safety Lead in healthcare Institutions are available in the device safety information.
For all of the latest safety notices from the MHRA on drugs and medical devices, see Alerts and recalls for drugs and medical devices.
Article citation: Drug Safety Update volume 15, issue 8: March 2022: 5.