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

MDR 024-05/23

Company name

Cipla (EU) Limited, UK

Product name

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

SNOMED Code

40504911000001103

Batch Number Expiry Date Pack Size First Distributed
ID12472 09/2023 1 x 60 15/02/2022

Active Pharmaceutical Ingredient:Fluticasone Propionate & Salmeterol xinafoate

Product name

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

SNOMED Code

35430111000001100

Batch Number Expiry Date Pack Size First Distributed
IB20103 11/2023 1 X 200 MD 27/05/2022
IB20104 11/2023 1 X 200 MD 27/05/2022
IB20105 11/2023 1 X 200 MD 27/05/2022
IB20532 03/2024 1 X 200 MD 15/09/2022

Active Pharmaceutical Ingredient:Beclometasone dipropionate anhydrous

Product name

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

SNOMED Code

35430311000001103

Batch Number Expiry Date Pack Size First Distributed
IB20106 11/2023 1 X 200 MD 23/06/2022
IB20107 11/2023 1 X 200 MD 30/05/2022
IB20108 11/2023 1 X 200 MD 01/07/2022
IB20543 03/2024 1 X 200 MD 25/11/2022
IB20544 03/2024 1 X 200 MD 13/09/2022
IB20545 03/2024 1 X 200 MD 13/09/2022
IB20546 03/2024 1 X 200 MD 15/09/2022
IB20547 03/2024 1 X 200 MD 20/09/2022
IB20548 03/2024 1 X 200 MD 31/10/2022

Active Pharmaceutical Ingredient: Beclometasone dipropionate anhydrous

Product name

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

SNOMED Code

41536211000001102

Batch Number Expiry Date Pack Size First Distributed
IC0112246 01/2024 1 X 1’s 30/07/2022

Active Pharmaceutical Ingredient: Icatibant

Company name

PHARMATHEN S.A.

Product name

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

SNOMED Code

15907411000001101

Batch Number Expiry Date Pack Size First Distributed
1206250 07/2025 28 04/08/2022
1206284 07/2025 28 04/08/2022
1206285 07/2025 28 04/08/2022
1206235 07/2025 28 04/08/2022
1206212 07/2025 28 04/08/2022
1206234 07/2025 28 04/08/2022
1206041 07/2025 28 04/08/2022
1206149 07/2025 28 04/08/2022
1206152 07/2025 28 04/08/2022
1206211 07/2025 28 04/08/2022

Active Pharmaceutical Ingredient: Clopidogrel

Brief description of the 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 for 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 for 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.

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

Recipients of this Medicines Notification 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 Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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

Updates to this page

Published 13 July 2023