Class 2 Medicines : Norgine Pharmaceuticals Limited, Pedmarqsi 80
OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Class 4 Medicines Defect Notification: Neuraxpharm UK Limited Recall: Neuraxpharm UK Limited have informed
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information.
Hazard
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information.
What consumers should do
for Healthcare Professionals: Healthcare professionals are advised that the current Patient Information Leaflet (PIL) for Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet does not contain all the information included in the corresponding reference product information. 1. Healthcare professionals, including GPs, independent prescribers and specialist prescribers, involved in prescribing Levetiracetam should continue to prescribe and dispense Levetiracetam Neuraxpharm in accordance with the approved product information and manage patients according to their individual clinical circumstances. Healthcare Professionals should be informed: that the approved indication includes use in infants from one month of age. of the information relating to very rare SCN8A mutation-associated early-onset epilepsy. that there is evidence suggesting a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS). that obsessive-compulsive disorder (OCD) is a recognised very rare adverse reaction. that multiorgan hypersensitivity reactions is a recognised rare adverse reaction. The following text has been included from other brands of levetiracetam products (re
Official recall notice
Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: October 1, 2026
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