MHRA Issues Class 4 Defect Notification for Martindale Clobazam Oral Suspension

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. 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. Martindale Pharmaceuticals Ltd Active ingredient: clobazam SNOMED code: 42289011000001100 Active ingredient: clobazam SNOMED code: 42289711000001100 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. Example for 5mg/5mL 150mL pack: The associated strength and bottle size documented on the pre-printed package remain correct and unchanged. Full batch quantities: Batch 0162858: 5,544 units Batch 0163605: 2,277 units Batch 0163858: 4,631 units 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: Licensed@ethypharm.com 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. Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU Telephone +44 (0)20 3080 6574 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 Contents Is this page useful? Maybe Yes this page is useful No this page is not useful Thank you for your feedback Report a problem with this page Help us improve GOV.UK Do not include personal or financial information like your National Insurance number or credit card details. To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab and requires JavaScript ) .