In February 2022, the following letters were sent or provided to affected healthcare professionals:
Medication Recalls and Notifications
In February 2022, drug recalls and notifications were issued on:
Class 4 Drug Defect Information: Flamingo Pharma UK Ltd, Ibuprofen Tablets 400mg, EL (22)A/04. Posted February 1, 2022. A batch of ibuprofen 400mg tablets has been identified and contains cartons with illegible embossed batch numbers. This poses a traceability risk in the event of a future recall. The batch number on the tablet blisters is clear and there is no problem with the quality of the product. Healthcare professionals should check the blister packs before dispensing the affected lot to ensure that the lot number can be read.
Company-led drug recall: Bucain Hyperbar 5 mg/ml, solution for injection (unlicensed drug), CLMR (22)A/01. Published February 14, 2022. One lot 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. It is an unauthorized drug that is only supplied to hospital pharmacies. Immediately stop supplying the batch, quarantine all remaining stock and return it to the UK importer.
Recall of class 2 drugs: hameln pharma ltd, Water for injections BP – 100 ml bottle, EL (22)A 06. Published on February 15, 2022. A batch of water for injections 100 ml bottle is recalled by measurement of precaution due to out-of-spec results for pH and conductivity in stability testing. Immediately stop supplying the batch, quarantine all remaining stock and return it to the supplier.
Class 2 drug recall: Uni Health Distribution, Efudix 5% w/w cream, EL (22)A 07. Issued February 17, 2022. One lot of Efudix (fluorouracil) 5% w/w cream is being recalled from pharmacies by precautionary measure measure because cartons may contain patient information leaflets for a different medicine. Immediately stop supplying the batch, quarantine all remaining stock and return it to the supplier. Healthcare professionals are encouraged to share an appropriate package insert with the patient whenever possible.
Recall of class 2 medicinal products: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50 mg/ml, solution for injection (2500 mg/50 ml vial), EL (22)A 08. Published February 17, 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 cover slip particles identified during stability testing. Immediately stop supplying the batch, quarantine all remaining stock and return it to the supplier.
UPDATE: Class 4 Drug 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. Published February 23, 2022. This is an update to Class 4 Drug Defect Information published February 3, 2022. contain patient information leaflets that omit drug interaction wording for the naproxen with aspirin (acetylsalicylic acid). Healthcare professionals dispensing any of the affected lots are asked to provide an updated patient information leaflet. Healthcare professionals should also remind patients to seek medical attention if taking aspirin (acetylsalicylic acid) with Naprosyn tablets or Naprosyn EC gastro-resistant tablets due to increased risk of bleeding when these drugs are taken simultaneously.
Medical Device Safety Information
In February 2022, MHRA device safety information pages were published at:
Surdial X hemodialysis machine: potential for devices to remove excess fluid outside of machine specifications. DSI/2022/002. Posted 17th February 2022. The MHRA is aware of cases of Surdial X hemodialysis machines removing excess fluid by ultrafiltration outside of its specifications. There is a low risk of dialysis-induced hypotension in patients unable to tolerate excessive 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 continues to investigate this matter. Actions for Nephrology Unit Leaders, Nephrology Nurses, and Nephrology Technicians are available in the Device Safety Information.
Stop using Vaginal Specula with Smoke Tube and Gynecological Hysteroscopy Sheaths from Gemini Surgical UK: All Lots and Lots. DSI/2022/001. Posted 17th February 2022. The MHRA has learned that the Cusco Medium Insulated Speculum with Smoke Tubes and Gynecological Hysteroscopy Sheaths from Gemini Surgical UK or Gemini Medical Innovations is being sold with a CE mark incorrectly applied. This means that these devices were sold without proof of safety and were manufactured to unknown standards. Stop using these devices and use an appropriate alternative. Actions for the patient safety officer in healthcare facilities are available in the device safety information.
For all the latest MHRA safety notices on medicines and medical devices, see Medicines and medical devices alerts and recalls.
Article citation: Drug Safety Update Volume 15, Issue 8: March 2022: 5.