Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension , EL (22)A/39
Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for 2 batches of Atorvastatin 4mg/ml Oral Suspension and 2 batches of Sildenafil 10mg/ml Oral Suspension.
MDR Number
MDR 027-09/22
Company name
Rosemont Pharmaceuticals Ltd.
Product description
Atorvastatin 4mg/ml Oral Suspension PL 00427/0256
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| ATV21001 | Apr-2024 | 150 ml | 28-Apr-2022 |
| ATV21002 | Apr-2024 | 150 ml | 13-Jul-2022 |
Active Pharmaceutical Ingredient: Atorvastatin
Sildenafil 10mg/ml Oral Suspension PL 00427/0258
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| SLD22001 | Mar-2025 | 122 ml | Not yet distributed |
| SLD22002 | Apr-2025 | 122 ml | 22-Jun-2022 |
Active Pharmaceutical Ingredient: Sildenafil
Brief description of the problem
Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for the above 2 batches of Atorvastatin 4mg/ml Oral Suspension (indicated for hypercholesterolaemia and prevention of cardiovascular disease) and 2 batches of Sildenafil 10mg/ml Oral Suspension (indicated for pulmonary arterial hypertension). The correct expiry dates (as stated in the above table) are printed on the bottle label and on the outer carton. All other product details are correct, including the serial numbers and batch numbers.
Advice for healthcare professionals
There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals should advise patients of the issue when dispensing these products. The products can be used until the expiry date printed on the bottle label and the outer carton. The expiry date stamped on the base of the bottle should be ignored. No other batches of Atorvastatin 4mg/ml Oral Suspension or Sildenafil 10mg/ml Oral Suspension marketed by Rosemont Pharmaceuticals are affected by this discrepancy.
Advice for patients
Patients should note that the expiry date printed on the base of the bottle for these products is incorrect and should be ignored. There are no concerns about the safety or quality of the medicine. The expiry date is correct on the bottle label and the outer carton (box). Patients should use these products until the expiry date on the bottle label and outer carton. If a patient has any concerns, they should contact their pharmacist.
Further Information
For further information please contact: pharmacovigilance@rosemontpharma.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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