MHRA: Clobazam Martindale Barcode Defect EL(26)A/38 Class 4 Notification

• Martindale Pharmaceuticals identified an error in the linear barcode of specific batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.
• The linear barcode incorrectly displays the GTIN for the branded product, Tapclob, instead of the generic Clobazam, while the 2D barcode remains accurate.
• The MHRA issued a Class 4 Medicines Defect Notification (EL(26)A/38), advising healthcare professionals to use only the 2D barcode for product identification and traceability.
• There is no risk to product quality or patient safety, and therefore, no recall has been issued for the affected batches.
• Future batches will use stickers to correct the linear barcode until new cartons are available, ensuring continued supply.

Compliance officers and legal counsel for pharmaceutical wholesalers and pharmacies must ensure their clients are fully aware of this specific barcode defect for Clobazam Oral Suspension and update internal procedures to rely solely on the 2D barcode for authentication and traceability, avoiding the linear barcode to prevent misidentification or non-compliance with MHRA guidelines.

Martindale Pharmaceuticals recently notified the Medicines and Healthcare products Regulatory Agency (MHRA) about a significant error affecting the linear barcode on specific batches of its Clobazam oral suspension. The affected products include both the 5 mg/5 mL and 10 mg/5 mL strengths, packaged in 150 mL bottles. This pharmaceutical barcode error UK means that the pre-printed linear barcode on the outer cartons incorrectly displays the Global Trade Item Number (GTIN) associated with the branded version of the product, known as Tapclob, rather than the correct GTIN for the generic Clobazam.

Crucially, while the linear barcode is erroneous, the serialized 2D barcode present on these packages remains accurate and correctly identifies the product. The issue is strictly confined to the outer packaging's linear barcode, with no impact on the quality, safety, or efficacy of the medicine itself. The strength and bottle size information printed on the packaging also remain correct and unaltered. Consequently, the MHRA has confirmed that there is no risk to product quality, and therefore, no product recall has been initiated for the affected batches.

The batches identified with this defect are 0162858 (comprising 5,544 units), 0163605 (2,277 units), and 0163858 (4,631 units). To address the issue for future production, Martindale Pharmaceuticals will apply corrective stickers to subsequent batches of Clobazam oral suspension for both strengths and pack sizes. This temporary measure will ensure accurate identification until new cartons with the corrected linear barcode can be manufactured and introduced, thereby maintaining a consistent supply for patients.

The MHRA issued a Class 4 Medicines Defect Notification, EL(26)A/38, to alert healthcare professionals and the supply chain about this specific MHRA Clobazam Martindale barcode defect. This notification underscores the importance of accurate drug traceability Clobazam within the pharmaceutical distribution network. The agency has provided clear guidance, advising healthcare professionals to rely exclusively on the serialized 2D barcode for product authentication and traceability purposes, as it is the only accurate identifier on the affected packaging.

Conversely, the linear barcode on the carton should not be used for product identification to prevent potential misidentification or errors in dispensing and inventory management. The MHRA specifically highlighted the need for additional precautions by wholesalers and pharmacies that utilize linear barcodes within their operational facilities. Compliance officers and legal counsel for these entities must ensure their clients are fully aware of this specific barcode defect for Clobazam Oral Suspension and update internal procedures to rely solely on the 2D barcode for authentication and traceability, avoiding the linear barcode to prevent misidentification or non-compliance with MHRA guidelines.

This directive is critical for maintaining the integrity of the supply chain and ensuring that the correct medication reaches patients without confusion, despite the packaging anomaly. The notification serves as a reminder of the stringent standards required for pharmaceutical labeling and the robust systems in place to identify and communicate such defects.

For patients currently using Clobazam oral suspension, the MHRA's notification confirms that no action is required on their part. The medicine itself is not affected by the barcode error, and its quality and safety remain uncompromised. Patients who have questions about their medication or experience any adverse reactions should, as always, seek medical attention and report suspected adverse reactions through the MHRA Yellow Card scheme.

The broader implication of this MHRA Clobazam Martindale barcode defect EL(26)A/38 lies in the operational adjustments required across the pharmaceutical supply chain. While the defect does not pose a direct health risk, it necessitates a procedural change for those involved in handling and dispensing the product. The emphasis on using the 2D barcode for accurate identification reinforces the industry's move towards more robust, serialized tracking systems to enhance drug traceability and patient safety.

This incident highlights the continuous vigilance required from manufacturers, distributors, and pharmacies to ensure that all aspects of pharmaceutical packaging and identification meet regulatory standards. The proactive communication from Martindale Pharmaceuticals and the clear guidance from the Medicines and Healthcare products Regulatory Agency are crucial in managing such defects effectively and minimizing any potential disruption or confusion in the healthcare system.

Compliance officers and legal counsel for pharmaceutical wholesalers and pharmacies must ensure their clients are aware of this specific barcode defect for Clobazam Oral Suspension and update internal procedures to rely solely on the 2D barcode for authentication and traceability, avoiding the linear barcode to prevent misidentification or non-compliance with MHRA guidelines.

Source: Original reporting via GOV.UK