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