Class 4 Medicines Defect Information: Cipla (UK) Limited and Pharmathen S.A – Various Products

Drug alert number:EL (23)A/24

Date issued: 13 July 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Cipla (UK) Limited and Pharmathen S.A – Various Products

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.

View full alert here.

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.

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