Star Pharmaceuticals Enalapril Maleate Defect EL(26)A/48: MHRA Class 4 Labelling Error

• Star Pharmaceuticals Limited reported a typographical error on the front carton of Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg Tablets, incorrectly stating "12. mg" instead of "12.5 mg."
• The MHRA issued a Class 4 Medicines Defect Notification (EL(26)A/48), confirming the defect does not impact tablet quality and poses a low risk.
• The correct hydrochlorothiazide strength is accurately displayed on other parts of the packaging and in the patient information leaflet.
• Healthcare professionals are advised to continue dispensing the product and reassure patients about the correct dosage.
• Patients should continue their prescribed medication and seek advice from healthcare providers for any concerns or to report adverse reactions.

This Class 4 Medicines Defect Notification, while identifying a labelling error, explicitly states the product quality is unaffected and dispensing should continue.

Star Pharmaceuticals Limited recently informed the Medicines and Healthcare products Regulatory Agency (MHRA) about a specific labelling discrepancy affecting their Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg Tablets. This particular Star Pharmaceuticals Enalapril maleate defect EL(26)A/48 involves a typographical error hydrochlorothiazide strength printed on the front face of the product carton. The label incorrectly displays "12. mg" instead of the accurate "12.5 mg" for the hydrochlorothiazide component.

This Enalapril maleate/Hydrochlorothiazide labelling error is isolated to the front of the carton. Crucially, the correct strength of 12.5 mg is accurately presented on all other faces of the carton, within the patient information leaflet, and on the blister foil packaging. A total of 1740 packs of the affected Star Pharmaceuticals Limited product defect have been distributed across the UK market, prompting the official notification from the regulatory body.

In response to the reported issue, the MHRA issued a Class 4 Medicines Defect Notification, identified as EL(26)A/48 defect notification. This classification indicates that while a defect exists, it is not considered to pose a significant risk to patients. The agency has explicitly stated that the quality of the tablets themselves remains entirely unaffected by this labelling discrepancy.

The risk associated with this specific typographical error is assessed as low. This determination is based on the fact that there are no other existing strengths of enalapril maleate/hydrochlorothiazide combination products where the hydrochlorothiazide component is expressed as 12 mg. This absence of a similar strength significantly reduces the potential for patient confusion or incorrect dosing due to the misprint.

Healthcare professionals are advised to take note of the details provided in this notification but are instructed to continue dispensing the affected product as usual. The primary guidance for these professionals is to reassure patients, should they raise concerns, that the medication is indeed enalapril maleate 20 mg / hydrochlorothiazide 12.5 mg tablets, precisely as detailed in the Patient Information Leaflet. This proactive reassurance aims to prevent unnecessary anxiety among patients.

Patients are strongly encouraged to continue taking their medication as prescribed, understanding that the quality of the tablets is not compromised. For any uncertainties or questions regarding their medication, patients should seek advice from their pharmacy or other healthcare professionals involved in their treatment. In cases of suspected adverse reactions or other medication-related concerns, individuals should seek medical attention and report any such reactions via the MHRA Yellow Card scheme. For specific medical information inquiries about this product, Star Pharmaceuticals Limited has provided contact details: info@drugsrus.co.uk or telephone 020 8423 2111.

This Class 4 Medicines Defect Notification, while identifying a labelling error, explicitly states the product quality is unaffected and dispensing should continue. This indicates a low-risk issue not requiring a product recall, but necessitates clear communication protocols for healthcare professionals to reassure patients and manage inquiries, mitigating potential liability arising from patient confusion. For pharmaceutical companies, this incident underscores the critical importance of stringent quality control processes in packaging and labelling, even for seemingly minor typographical errors.

Compliance officers and legal counsel within both pharmaceutical manufacturing and healthcare provision sectors should recognize the implications of such a notification. While the immediate risk is low, the need for clear, consistent communication from healthcare providers is paramount. Ensuring that all relevant contacts, including community pharmacists and dispensing general practitioners, are informed and equipped to address patient questions can prevent misunderstandings and uphold patient trust, thereby reducing the potential for future legal or reputational challenges.

Compliance officers and legal counsel for pharmaceutical companies or healthcare providers should note that this Class 4 defect notification, while identifying a labelling error, explicitly states the product quality is unaffected and dispensing should continue. This indicates a low-risk issue not requiring a product recall, but necessitates clear communication protocols for healthcare professionals to reassure patients and manage inquiries, mitigating potential liability arising from patient confusion.

Source: Original reporting via GOV.UK