The Spanish Agency for Medicines and Health Products (AEMPS) has detected impurities above the accepted limit in several batches of Pfizer manufactured Acuprel hypertension drug.
Quality defects in blood pressure drug
The AEMPS classifies drug quality defects into three categories (1, 2, and 3). Moreover, the first corresponds to a higher risk, and class three with a lower risk. In this case, AEMPS points out that it is a class two defect which is above the established limit.
Batches withdrawn
As a result, and as a precautionary measure, the affected batches are being withdrawn from all market distributers and should be returned to the laboratory through the usual channels.
Consequently, if you are using this to control high blood pressure, please check the batch numbers below. Furthermore, return any you may have with these numbers to the pharmacy.
Trademark, presentation, registration number and national code:
- ACUPREL 20 mg FILM-COATED TABLETS, 28 tablets (NR: 59082, CN: 725150)
- ACUPREL 40 mg FILM-COATED TABLETS, 28 tablets (NR: 61710, CN: 667964)
- ACUPREL 5 mg FILM-COATED TABLETS, 60 tablets (NR: 59081, CN: 731919)
Lots and expiry dates:
- ACUPREL 20 mg FILM-COATED TABLETS, 28 tablets (NR: 59082, CN:
725150)- Batch: DT1726, expiry date 04/30/2023
- Lot: EP6755, expiry date 09/30/2023
- Lot: FF8049, expiry date 09/30/2023
- Lot: FJ7223, expiry date 09/30/2023
- Lot: FM6653, expiry date 09/30/2023
- ACUPREL 40 mg FILM-COATED TABLETS, 28 tablets (NR: 61710, CN: 667964)
- Batch: CY1994, expiry date 09/30/2022
- Batch: DT1722, expiry date 09/30/2022
- Lot: EM1564, expiry date 12/31/2022
- Batch: FA3732, expiry date 12/31/2022
- Lot: FJ1093, expiry date 04/30/2024
- ACUPREL 5 mg FILM-COATED TABLETS, 60 tablets (NR: 59081, CN: 731919)
- Lot: FF2036, expiry date 05/31/2024
ACE inhibitors
According to AEMPS, Acuprel belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. These are medicines from the group of antihypertensives that act by dilating blood vessels in the body.
Acuprel is indicated for the treatment of patients with high blood pressure (hypertension). And also, for the treatment of patients with a heart disease known as chronic heart failure, associated with their usual treatment.
Furthermore, treatment with Acurel requires regular monitoring by your doctor.
Key facts according to the World Health Organisation (WHO)
- Hypertension ̶ or elevated blood pressure ̶ is a serious medical condition that significantly increases the risks of heart, brain, kidney, and other diseases.
- Furthermore, an estimated 1.28 billion adults aged 30-79 years worldwide have hypertension, most (two-thirds) living in low- and middle-income countries
- An estimated 46% of adults with hypertension are unaware that they have the condition.
- Less than half of adults (42%) with hypertension are diagnosed and treated.
- Moreover, approximately only 1 in 5 adults (21%) with hypertension have it under control.
- Consequently, hypertension is a major cause of premature death worldwide.
- One of the global targets for noncommunicable diseases is to reduce the prevalence of hypertension by 33% between 2010 and 2030.
World hypertension day
Furthermore, most people with high blood pressure go undetected as there are often no symptoms. World hypertension day is on May 17th. Moreover, the focus this year is to create awareness about the importance of measuring blood pressure on a regular basis.
Most pharmacies in Spain will take your blood pressure reading free of charge. However, if they have a machine there will be a nominal fee.
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