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
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