Class 4

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 025-09/22

Company name: Rosemont Pharmaceuticals Ltd.

Details of the affected batches:

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

 

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

Brief description of 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 to 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 to 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.

Company contacts for further information:

For further information please contact: pharmacovigilance@rosemontpharma.com

To access the full recall: Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension , EL (22)A/39