Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Ltd, Cozaar 100mg film-coated tablets, EL(24)A/01
Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets.
MDR Number
MDR 197-11/23
Company name
Quadrant Pharmaceuticals Ltd
Product description
Cozaar 100mg film-coated tablets, PLPI 20774/1830
Product information
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 6016W | 31/08/2025 | 28 | 08/11/2023 |
| 5584W | 31/08/2025 | 28 | 23/10/2023 |
| 5393W | 31/08/2025 | 28 | 18/10/2023 |
| 5474W | 31/08/2025 | 28 | 18/10/2023 |
| 5169W | 31/03/2025 | 28 | 11/10/2023 |
| 5164W | 30/06/2025 | 28 | 10/10/2023 |
| 5171W | 31/08/2025 | 28 | 06/10/2023 |
Active Pharmaceutical Ingredient: Losartan Potassium
Brief description of the problem
Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Cozaar 100mg film-coated tablets.
The PIL does not include the most up to date safety information as described below. In Section 2 ‘What you need to know before you take Cozaar’, sub section ‘Cozaar with food and drink’ the following information is missing: ‘Grapefruit juice should be avoided while taking Cozaar.’
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL.
The updated PIL is available here: https://www.medicines.org.uk/emc/product/7798/pil or by contacting licensing@maxearn.co.uk
If it is not possible to provide an updated PIL please advise patients of the missing information and discuss with them whether the medicine is suitable for them. Quadrant Pharmaceuticals Ltd has confirmed that all future imported batches will contain the correct PIL.
Upon request, Quadrant Pharmaceuticals Ltd will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.
Advice for patients
Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
Patients are advised that grapefruit juice should be avoided while taking Cozaar.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Further information
For medical information enquiries please contact licensing@maxearn.co.uk
For stock control enquiries please contact licensing@maxearn.co.uk
Recipients of this Medicines Recall 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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