| Risk Statement | The subject product has been declared Spurious, as laboratory analysis confirmed absence of the stated active ingredient (Cefixime), resulting in complete therapeutic failure. Packaging comparison with the genuine manufacturer’s QC retention sample revealed significant discrepancies in printing, hologram security features, blister demarcation, and labeling details, confirming it is not an authentic product. Use of this falsified antibiotic may lead to disease progression, complications, and increased antimicrobial resistance. The risk to public health is assessed as high, particularly for patients requiring effective antibacterial therapy. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |
