Class 4 Medicines Notification, Cipla (UK) Limited and Pharmathen S.A., Various Products, EL(23)A24

Cipla (EU) Limited, UK and Pharmathen S.A. have informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine (POM).

MDR Numbers: MDR 002-07/23 and MDR 024-05/23

Company name: Cipla (EU) Limited, UK

Product description: Sereflo Ciphaler 50 microgram/250 microgram/dose Inhalation powder, Pre-Dispensed BP, PL 36390/0267

SNOMED Code: 40504911000001103

Details of the affected batch:

Active Pharmaceutical Ingredient: Fluticasone Propionate & Salmeterol xinafoate

 

Product description: Kelhale 50 micrograms per actuation pressurised inhalation solution, PLGB 36390/0319

SNOMED Code: 35430111000001100

Details of the affected batch:

Active Pharmaceutical Ingredient: Beclometasone dipropionate anhydrous

 

Product description: Kelhale 100 micrograms per actuation pressurised inhalation solution, PLGB 36390/0320

SNOMED Code: 35430311000001103

Details of the affected batch:

Active Pharmaceutical Ingredient: Beclometasone dipropionate anhydrous

 

Product description: Icatibant 30 mg solution for injection in pre-filled syringe, PLGB 36390/0285

SNOMED Code: 41536211000001102

Details of the affected batch:

Active Pharmaceutical Ingredient: Icatibant

 

Company name: PHARMATHEN S.A.

Product description: Grepid 75 mg film coated tablets (Kent Pharma Livery), PLGB 17277/0398

SNOMED Code: 15907411000001101

Details of the affected batch:

Active Pharmaceutical Ingredient: Clopidogrel

 

Brief description of problem:

Cipla (EU) Limited, UK has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine ‘POM.’

Pharmathen S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75 mg film coated tablets is missing the medicines legal classification for a Prescription Only Medicine ‘POM.’

This only impacts the batches listed in this notification. Both Cipla (EU) Limited, UK and Pharmathen S.A. have confirmed that all future batches will include ‘POM’ on the outer carton (box). There is no impact to the product quality or safety and due to considerations, that these medicines are only supplied against a valid prescription, these batches are not being recalled.

Advice to Healthcare Professionals:

Healthcare professionals are advised to exercise caution when handling the listed products and ensure that they are stored accordingly and in line with the guidance for the storage of Prescription Only Medicines (POM). Additionally, healthcare professionals are reminded to only dispense these products when the pharmacy team receives a suitable prescription prescribed by a qualified health professional.

Advice to Patients:

This issue is about missing information on the outer carton (box). The medicine itself is not affected and therefore patients do not need to take any action.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. If you have any concerns, 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 their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

Cipla (UK) Limited

For more information regarding Cipla (EU) Limited, UK products, medical or supply enquiries, please contact telephone: +44 (0) 800 047 2144 or via email: drugsafety@Cipla.com & Uk.info@Cipla.com

Pharmathen S.A

For more information regarding Pharmathen S.A products, medical or supply enquiries, please contact telephone: +30 210 6604300 or via email: pharmacovigilance@pharmathen.com & info@pharmathen.com

To access the full recall:  https://assets.publishing.service.gov.uk/media/64ae77bc8bc29f00132ccb57/EL_23_A24.pdf