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 Number: DMRC- 39567957

Company name:Macarthys Laboratories Ltd Trading as Martindale Pharma

Product descriptions and details of the affected batches:

Xaggitin XL 18 mg Prolonged-release Tablets - PL: 01883/0359, SNOMED code: 34248211000001101, GTIN: 05060078672023

Xaggitin XL 27 mg Prolonged-release Tablets - PL: 01883/0360, SNOMED code: 34248911000001105, GTIN: 05060078670227

Xaggitin XL 36 mg Prolonged-release Tablets - PL: 01883/0361, SNOMED code: 34248411000001102, GTIN: 05060078672030

Xaggitin XL 54 mg Prolonged-release Tablets - PL: 01883/0362, SNOMED code: 34248711000001108, GTIN: 05060078672047

Background information: 

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 to 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 to 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.

Company contacts for further 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.

To access the full recall/alert: Class 4 Medicines Defect Notification: Macarthys Laboratories Ltd T/A Martindale Pharma, Xaggitin XL tablets, EL(26)A/35