Class 4 Medicines Defect Notification: Macarthys Laboratories Ltd T/A Martindale Pharma, Xaggitin XL Prolonged-release Tablets, EL(26)A/35
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.
DMRC reference number
DMRC- 39567957
Marketing Authorisation Holder
Macarthys Laboratories Ltd Trading as Martindale Pharma
Medicine Details
Xaggitin XL 18 mg Prolonged-release Tablets
PL: 01883/0359
Active ingredient: methylphenidate hydrochloride
SNOMED code: 34248211000001101
GTIN: 05060078672023
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 183155 | 30/10/2027 | 30 tablets | 17/03/2026 |
| 185442 | 31/12/2027 | 30 tablets | Not yet distributed |
Medicine Details
Xaggitin XL 27 mg Prolonged-release Tablets
PL: 01883/0360
Active ingredient: methylphenidate hydrochloride
SNOMED code: 34248911000001105
GTIN: 05060078670227
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 174975 | 31/05/2027 | 30 tablets | 18/02/2026 |
| 175037 | 31/05/2027 | 30 tablets | 21/05/2026 |
| 178223 | 31/07/2027 | 30 tablets | 17/04/2026 |
| 183931 | 30/11/2027 | 30 tablets | Not yet distributed |
| 185438 | 30/11/2027 | 30 tablets | Not yet distributed |
| 185439 | 30/11/2027 | 30 tablets | Not yet distributed |
| 185440 | 30/11/2027 | 30 tablets | 07/04/2026 |
| 187560 | 28/02/2028 | 30 tablets | Not yet distributed |
Medicine Details
Xaggitin XL 36 mg Prolonged-release Tablets
PL: 01883/0361
Active ingredient: methylphenidate hydrochloride
SNOMED code: 34248411000001102
GTIN: 05060078672030
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 175426 | 30/06/2027 | 30 tablets | 12/03/2026 |
| 175428 | 30/06/2027 | 30 tablets | 18/05/2026 |
| 176698 | 30/06/2027 | 30 tablets | 17/03/2026 |
| 176699 | 30/06/2027 | 30 tablets | Not yet distributed |
| 176700 | 30/06/2027 | 30 tablets | Not yet distributed |
| 182875 | 30/09/2027 | 30 tablets | 06/05/2026 |
| 183003 | 31/10/2027 | 30 tablets | Not yet distributed |
Medicine Details
Xaggitin XL 54 mg Prolonged-release Tablets
PL: 01883/0362
Active ingredient: methylphenidate hydrochloride
SNOMED code: 34248711000001108
GTIN: 05060078672047
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 178338 | 31/07/2027 | 30 tablets | 09/02/2026 |
| 178432 | 31/07/2027 | 30 tablets | 31/03/2026 |
| 178481 | 31/07/2027 | 30 tablets | 18/05/2026 |
| 180343 | 30/09/2027 | 30 tablets | 08/06/2026 |
| 187926 | 28/02/2028 | 30 tablets | 03/07/2026 |
| 187927 | 28/02/2028 | 30 tablets | Not yet distributed |
| 187928 | 28/02/2028 | 30 tablets | Not yet distributed |
| 187929 | 28/02/2028 | 30 tablets | Not yet distributed |
| 187930 | 28/02/2028 | 30 tablets | Not yet distributed |
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 Controlled Drug in practices.
The quality of the tablets is not impacted by this defect and therefore the product is not being recalled.
Advice for Healthcare Professionals:
Please physically check the quantity of tablets when receiving the packs and when dispensing these tablets, this may include breaking the tamper evident seal. Please report any affected packs to licensed@ethypharm.com using the reference Ethypharm supply for any reconciliation excursions experienced due to this defect.
Be aware that patients may return for their next prescription earlier than expected.
Advice for Patients:
Patients should be aware that some packs of the affected batches may have an incorrect number of tablets in the bottle, leading to missing or additional tablets.
Patients may continue to take the tablets prescribed by your doctor as the quality of the tablets is not impacted by this defect.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information:
For all medical information enquiries and information on this product, please email medinfo@ethypharm.com or telephone 01277 266 600 Selecting Option 2.
For stock control enquiries please email licensed@ethypharm.com, or telephone 01628 551900.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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