Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21
Source: gov.uk (2025-05-13)

Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.

DMRC reference number

DMRC-35334505

Marketing Authorisation Holder

Chemidex Pharma Ltd

Medicine Details

Predfoam 20mg/dose Rectal Foam, Prednisolone 20mg/dose Rectal Foam

PL17736/0130

Active Ingredient: prednisolone

SNOMED code: 38753811000001101

Beclometasone dipropionate 0.25 mg/g Cream

PL17736/0127

Active Ingredient: beclometasone

SNOMED code: 18436411000001103

Beclometasone dipropionate 0.25 mg/g Ointment

PL17736/0268

Active Ingredient: beclometasone dipropionate

SNOMED code: 18434811000001108

Clobetasol propionate/neomycin sulfate/nystatin 0.5 mg/5 mg/100,000 IU/g Cream

PL17736/0100

Active Ingredient: clobetasol propionate, neomycin sulfate, nystatin

SNOMED code: 18670711000001106

Clobetasol propionate/neomycin sulfate/nystatin 0.5 mg/5 mg/100,000 IU/g Ointment

PL17736/0101

Active Ingredient: clobetasol propionate, neomycin sulfate, nystatin

SNOMED code: 18670911000001108

Hydrocortisone 0.5% Cream

PL: 17736/0090

Active Ingredient: hydrocortisone

SNOMED code: 14943211000001105

Hydrocortisone 2.5% Cream

PL:17736/0092

Active Ingredient: hydrocortisone

SNOMED code: 14943911000001101

Hydrocortisone 2.5% Ointment

PL: 17736/0095

Active Ingredient: hydrocortisone

SNOMED code: 14944911000001104

Affected Lot Batch Numbers

See Download Document (https://assets.publishing.service.gov.uk/media/6821d60ddb6463b14cd818d7/Class_4_medicines_notification_Chemidex_Pharma_Ltd.pdf#page=4%20for%20batch%20numbers) for batch numbers

Background

Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.

The batches listed as ‘not yet distributed’ have also been packed with the PIL that is missing the additional side effect information. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in the notification and the expected distribution dates for these batches will take place from May 2025.

Advice for Healthcare Professionals:

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing these products

When product from batches included in the tables are supplied or dispensed, please ensure that patients are aware of the missing information.

The missing information is:

PIL Section 2

Contact your doctor if you experience blurred vision or other visual disturbances.

PIL Section 4

Side effects where the frequency is not known: Blurred vision.

Advice for Patients:

Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. The quality of the impacted batches is not affected which is why the products are not being recalled.

There is some missing information in the patient leaflet which is presented below:

Section 2

Contact your doctor if you experience blurred vision or other visual disturbances.

Section 4

Side effects where the frequency is not known: Blurred vision.

If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme (https://yellowcard.mhra.gov.uk/).

Additional information:

For medical information enquiries please email xxx@xxx.xx (mailto:xxx@xxx.xx) or telephone xx-xxxx-xxxx.

For stock control enquiries please email xxx@xxx.xx. (mailto:xxx@xxx.xx.)

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre10 South ColonnadeCanary WharfLondonE14 4PU

Telephone xx-xxxx-xxxx

xxx@xxx.xx (mailto:xxx@xxx.xx)

Download document

Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21 (https://assets.publishing.service.gov.uk/media/6821d60ddb6463b14cd818d7/Class_4_medicines_notification_Chemidex_Pharma_Ltd.pdf)