MHRA Class 4 Medicines Defect Information: Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension (Rosemont Pharmaceuticals Ltd)

Class 4 Medicines Defect Information:

Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension (Rosemont Pharmaceuticals Ltd)

Drug alert number: EL (22)A/39

Date issued: 14 September 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Atorvastatin 4mg/ml Oral Suspension PL 00427/0256

Batch Number Expiry Date Pack Size First Distributed
ATV21001 April 2024 150ml 28 April 2022
ATV21002 April 2024 150ml 13 July 2022

Active Pharmaceutical Ingredient: Atorvastatin

Sildenafil 10mg/ml Oral Suspension PL 00427/0258

Batch Number Expiry Date Pack Size First Distributed
SLD22001 March 2025 122ml Not yet distributed
SLD22002 April 2025 122ml 22 June 2022

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.

View full alert here

For further information please contact: pharmacovigilance@rosemontpharma.com

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