Tuzulby 20 mg prolonged-release chewable tablets
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC-40198117
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Tuzulby 20 mg prolonged-release chewable tablets | PL: 49718/0143 | methylphenidate hydrochloride | 8436027473978 |
| Tuzulby 30 mg prolonged-release chewable tablets | PL: 49718/0144 | methylphenidate hydrochloride | 8436027473985 |
| Tuzulby 40 mg prolonged-release chewable tablets | PL: 49718/0145 | methylphenidate hydrochloride | 8436027473992 |
Batches (expiry): 77951 (08/2028), 79949 (02/2029), 78001 (08/2028), 79961 (02/2029), 78011 (08/2028), 79974 (02/2029)
Background: Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for the above batches of Tuzulby prolonged release 20mg, 30mg and 40mg chewable tablets. The missing safety information relates to epistaxis (nosebleed). The omitted information concerns addition of epistaxis (frequency not known) as an adverse reaction within the Summary of Product Characteristics and Patient Information Leaflet, specifically: Summary of Product Characteristics (SmPC)