MHRA Issues Class 4 Defect Notification for Milpharm Loperamide Tablets
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Notification regarding Milpharm Limited's Loperamide hydrochloride 2 mg Orodispersible Tablets. The notification, dated May 11, 2026, identifies discrepancies in the Patient Information Leaflet (PIL) for batches 25882X3 and 25882X2. Specifically, the PIL incorrectly instructs patients to swallow the tablets with water, whereas they should be placed on the tongue to dissolve. Additionally, the leaflet omits a rare side effect: a burning or prickling sensation of the tongue. Despite these errors, the outer carton displays the correct administration instructions, mitigating safety risks. No adverse drug reactions have been reported. Healthcare professionals are advised to inform patients of the correct usage and potential side effects. Patients possessing the affected batches do not need to return the medication but should follow the instructions on the outer packaging. Milpharm Limited confirmed that future batches will include corrected leaflets. This action ensures patient safety while allowing continued use of the effective medication under proper guidance.
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MHRA Issues Class 4 Defect Notification for Milpharm Loperamide Tablets
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Notification regarding Milpharm Limited's Loperamide hydrochloride 2 mg Orodispersible Tablets. The notification, dated May 11, 2026, identifies discrepancies in the Patient Information Leaflet (PIL) for batches 25882X3 and 25882X2. Specifically, the PIL incorrectly instructs patients to swallow the tablets with water, whereas they should be placed on the tongue to dissolve. Additionally, the leaflet omits a rare side effect: a burning or prickling sensation of the tongue. Despite these errors, the outer carton displays the correct administration instructions, mitigating safety risks. No adverse drug reactions have been reported. Healthcare professionals are advised to inform patients of the correct usage and potential side effects. Patients possessing the affected batches do not need to return the medication but should follow the instructions on the outer packaging. Milpharm Limited confirmed that future batches will include corrected leaflets. This action ensures patient safety while allowing continued use of the effective medication under proper guidance.
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