Xaggitin XL 18 mg Prolonged-release 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- 39567957
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Xaggitin XL 18 mg Prolonged-release Tablets | PL: 01883/0359 | methylphenidate hydrochloride | 05060078672023 |
| Xaggitin XL 27 mg Prolonged-release Tablets | PL: 01883/0360 | methylphenidate hydrochloride | 05060078670227 |
| Xaggitin XL 36 mg Prolonged-release Tablets | PL: 01883/0361 | methylphenidate hydrochloride | 05060078672030 |
| Xaggitin XL 54 mg Prolonged-release Tablets | PL: 01883/0362 | methylphenidate hydrochloride | 05060078672047 |
Batches (expiry): 183155 (30/10/2027), 185442 (31/12/2027), 174975 (31/05/2027), 175037 (31/05/2027), 178223 (31/07/2027), 183931 (30/11/2027), 185438 (30/11/2027), 185439 (30/11/2027), 185440 (30/11/2027), 187560 (28/02/2028), 175426 (30/06/2027), 175428 (30/06/2027), 176698 (30/06/2027), 176699 (30/06/2027), 176700 (30/06/2027), 182875 (30/09/2027), 183003 (31/10/2027), 178338 (31/07/2027), 178432 (31/07/2027), 178481 (31/07/2027), 180343 (30/09/2027), 187926 (28/02/2028), 187927 (28/02/2028), 187928 (28/02/2028), 187929 (28/02/2028), 187930 (28/02/2028)
Background: Macarthys Laboratories Ltd T/A Martindale Pharma has notified the MHRA of a manufacturing issue impacting several batches of Xaggitin XL Prolonged-release Tablets, due to the occurrence of incorrect tablet counts in the bottles. Multiple complaints of incorrect quantities of tablets in packs of Xaggitin XL Prolonged-release Tablets have been received. The majority of reports are for missing tablets but extra tablets have also been reported. The batches listed as ‘not yet distributed’ may be impacted by the same issue. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in the notification. The defect appears to be impacting a low percentage of packs within a batch, impacting reconciliation of the Schedule 2 Contr
