The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified about a barcode error affecting specific batches of Fexofenadine Hydrochloride 120mg film-coated tablets. Distributed by Healthcare Pharma Limited, these tablets were manufactured by Chanelle Medical Unlimited Company. This alert targets clinical, quality, and regulatory teams responsible for pharmaceutical safety and compliance.
What has changed?
Chanelle Medical Unlimited Company recently identified an incorrect European Article Number (EAN) / Global Trade Item Number (GTIN) barcode on certain batches of Fexofenadine Hydrochloride 120mg film-coated tablets. This barcode error, reported by the company to the MHRA, can potentially lead to logistical disturbances, including challenges in stock identification and tracking within supply chains. Ensuring correct labeling remains a critical aspect of regulatory compliance.
Who will be affected?
The affected batches may impact pharmacies, wholesalers, distributors, and healthcare institutions, particularly those relying on barcode systems for inventory management. Regulatory and quality assurance teams within pharmaceutical organizations should assess the implications for operational compliance and patient safety. It is essential to verify whether affected products have been circulated within your supply network.
What does this mean for clinical teams?
Clinical teams should remain alert to any issues relating to inventory accuracy, as errors in barcode identification may delay access to specific medications. If a patient requires Fexofenadine Hydrochloride 120mg, teams should confirm with suppliers that the batch is unaffected or properly identified.
Steps for resolving the issue
To address this problem, Chanelle Medical recommends conducting internal audits of all inventory containing Fexofenadine Hydrochloride 120mg. If affected batches are identified, healthcare providers and distributors should contact Healthcare Pharma Limited or Chanelle Medical Unlimited Company for guidance. The MHRA advises stakeholders to follow traceability procedures and manage inventory corrections promptly.
How to report further concerns?
Stakeholders encountering additional issues related to this defect should report directly to the MHRA using established pharmacovigilance protocols. This ensures systematic tracking and resolution of the problem under regulatory standards.
Frequently Asked Questions
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1. What specific batches are affected?
Chanelle Medical has yet to publicly disclose the exact batch details. Regulatory bodies and distribution partners may contact the company for batch-specific identification.
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2. Will this impact patients?
The barcode error primarily affects logistical operations rather than the formulation or efficacy of the medication. However, clinical teams should remain vigilant for any indirect delivery challenges.
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3. Who can I contact for further clarity?
Healthcare Pharma Limited serves as the distributor, and Chanelle Medical provides manufacturing support. Both entities are available for inquiries regarding affected batches and resolutions.
Next steps
Pharmaceutical distribution teams should immediately review inventory and communication channels with suppliers. Regulatory specialists may need to update compliance documentation to reflect corrective actions. Stakeholders are encouraged to follow MHRA communications for ongoing updates.
Disclaimer
This content is provided for informational purposes. It is meant for professional audiences and does not constitute legal advice. Please refer to your regulatory body’s guidelines for detailed compliance instructions.
Original announcement
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-fexofenadine-hydrochloride-120mg-film-coated-tablets-chanelle-medical-unlimited-company-el-25-a-slash-41