We use some necessary cookies to make this website work properly.
We want to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other websites to help us provide content from their services.
You can change your cookie settings at any time.
Search the department to understand what the government is doing
Departments, institutions and public institutions
News reports, speeches, letters and announcements
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Free release of data, information and company reports
A summary of recent letters, drug recalls and notifications sent to healthcare professionals.
In November 2021, the following letters were sent or provided to relevant healthcare professionals:
In November 2021, drug recalls and notifications were issued:
Update: Type 4 drug deficiency information: Crescent Pharma Ltd, SyreniRing 0.120 mg/0.015 mg every 24 hours, vaginal delivery system, EL (20)A/36. Released on November 2, 2021. It has been determined that an additional batch of SyreniRing 0.120 mg/0.015 mg (etonogestrel and ethinyl estradiol) contains a patient information leaflet that lacks important safety-related text changes. An updated batch list was included in the original defect notice issued in August 2020. The healthcare professional distributing the product should ensure that the patient is aware of any missing information.
Type 4 drug deficiency information: Vygoris Limited, mitogen (mitomycin) 20mg powder, solution for injection/infusion or intravesical use, EL (21)A/27. Released on November 8, 2021 . Some Mitocin 20mg (mitomycin) powder vials for injection/infusion or intravesical use may contain invisible particles higher than current specifications after reconstitution. The manufacturer will include a disposable filter unit containing all future stocks of Mitocin 20mg, and healthcare professionals may ask the manufacturer to provide additional filters. It is recommended that healthcare professionals check existing inventory and ensure that disposable filters are used before treatment.
Class 2 drug recall: Cold and Flu Relief Capsules (GSL)-various livers, Wrafton Laboratories Limited (traded under the name of Perrigo), EL (21)A/28. Released on November 11, 2021. Due to errors in the product cartons and leaflets, various coated cold and flu relief capsules (paracetamol 300 mg, caffeine 25 mg, and phenylephrine hydrochloride 5 mg) are being recalled. The affected product erroneously stated that the dosage for individuals over 12 years old was 2 capsules every 4 to 6 hours, with a maximum of 12 capsules in any 24 hours. This exceeds the pediatric paracetamol limit for children 12-15 years old, where the correct dosage is a maximum of 8 capsules in any 24 hours. Stop supplying batches immediately, isolate all remaining inventory and return to the supplier.
Type 4 drug defect information: Slenyto 1 mg and 5 mg extended-release tablets-distributed by Flynn Pharma Ltd, EL (21)A/29. Released on November 15, 2021. It has been determined that batches of Slenyto 1 mg and 5 mg (melatonin) sustained-release tablets lack the important safety-related text in the patient information leaflet. The patient information leaflet for the affected batch does not contain detailed information on interaction with beta blockers or package size. It is recommended that healthcare professionals be cautious when distributing products and provide patients with updated patient information brochures when possible.
Company-led drug recall: Dotarem solution for injection (10 ml vial)-PL 12308/0016. Released on November 17, 2021. Due to leaks and potential loss of sterility due to defects in the glass bottleneck, batches of Dotarem (gadolinic acid) injection 10 ml vials are being recalled. Stop supplying batches immediately, isolate all remaining inventory and return to the supplier.
Class 2 drug recall: SANTEN Oy (traded as Santen UK Limited) and parallel distributors, IERVIS 1 mg/mL eye drops, lotions and VERKAZIA 1 mg/mL eye drops, lotions, EL (21)A/30. 2021 Released on November 18, 2015. Due to the detection of particles or crystals of the active ingredient during the stability test, batches of Ikervis 1mg/ml eye drops and Verkazia 1mg/ml eye drops (cyclosporine) were recalled. The marketing authorization holder has not received any reports of adverse events, but due to the presence of particles, it may cause eye irritation, eye pain or foreign body sensation. Stop supplying batches immediately, isolate all remaining inventory and return to the supplier.
Class 3 drug recall: Martindale Pharma, Ethypharm Group Company Methadone 5mg Tablets/Physeptone 5mg Tablets, EL (21)A/31. Released on November 22, 2021. Due to the discoloration of the blister bag film, as a preventive measure, a batch of 5 mg methadone tablets is being recalled. Stop supplying batches immediately, isolate all remaining inventory and return to the supplier.
Type 4 drug defect information: Diuril Oral Solution (unlicensed drug), Mawdsley-Brooks & Company Limited, EL (21)A/32. Released on November 29, 2021. The product information of the confirmed batch of Diuril (chlorothiazide) oral solution is incorrect. The patient information leaflet of the affected batch stated that the 0.4% alcohol content was incorrect, while the bottle, carton and patient information leaflet inside the package correctly stated the 0.5% alcohol content. It is recommended that healthcare professionals be careful when dispensing products and use the manufacturer's patient information booklet inserted in the package.
Type 4 drug deficiency information: mometasone furoate 50 micrograms/dose nasal spray, suspension, PilsCo Ltd, EL (21)A/33. Released on November 29, 2021. The instructions for the confirmed batch of mometasone furoate 50 micrograms nasal spray are incorrect. The bottle label of the affected batch incorrectly suggested that the product should be used within 2 weeks after the first use, because the correct statement is to use within 2 months after the first use. The correct wording is on the patient information booklet and the product box. It is recommended that healthcare professionals be cautious when dispensing the product and instruct patients to ensure that the product is used within 2 months after the first use.
Class 2 drug recall: various marketing authorization holders and parallel distributors, products containing irbesartan, EL(21)A/34. Issued on November 30, 2021. Many manufacturers and distributors are recalling the following batches of drugs: Aprovel (irbesartan) 150mg and 300mg film-coated tablets, Co-Aprovel (irbesartan and hydrochlorothiazide) 150mg/12.5mg, 300mg/12.5mg film Coated tablets Coated tablets. This is a preventive recall because it has been determined that the batch contains 5-(4'-(azidomethyl)-[1,1'-biphenyl]-2 yl)-1H-tetrazole, which is a kind of Impurities with mutagenic potential that exceed acceptable limits. Stop supplying batches immediately, isolate all remaining inventory and return to the supplier. Healthcare professionals should advise patients not to stop taking medication without consulting a doctor or pharmacist. As the investigation progresses, MHRA will provide further updates.
For all the latest notices, see Alerts, Recalls, and Safety Information.
Article citation: Drug Safety Update Volume 15, Issue 5: December 2021: 5.
Check what you need to do
Do not include personal or financial information, such as your National Insurance number or credit card details.
To help us improve GOV.UK, we would like to learn more about your visit today. We will send you a link to the feedback form. It only takes 2 minutes to fill in. Don't worry, we will not send you spam or share your email address with anyone.