Class 4 Medicines Defect Notification: Martindale Pharmaceuticals Ltd, Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml, EL(26)A/38

Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.

Clobazam Martindale Pharma 5 mg/5 mL Oral Suspension 150ml

Clobazam Martindale Pharma 10 mg/5 mL Oral Suspension 150ml

Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.

The above batches were packaged in cartons containing an incorrect pre-printed linear barcode. The linear barcode present represents the GTIN for the branded version of the product (Tapclob). It should instead reflect the generic name: Clobazam. The code in the 2D printed barcode is correct.

The associated strength and bottle size documented on the pre-printed package remain correct and unchanged.

Future batches of Clobazam for both strengths and pack size will have the barcode corrected via the application of a sticker until new cartons are available to maintain supply for patients.

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled.

Healthcare professionals are advised to note the above-mentioned batches of Clobazam Oral Suspension and use the serialized 2D barcode for authentication and traceability, as it remains accurate. The linear barcode on the carton should not be used for product identification.

Additional precautions should be considered by wholesalers and pharmacies using the linear barcode in a wholesale facility.

This notification relates to a barcode error on the outer packaging of the product. The medicine itself is not affected, and patients do not need to take any action.

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.

For further information, medical enquiries and stock information, contact: [email protected]