Rapid Alert
| DRAP Alert No | No I/S/02-24-07 |
| Action Date | 16th Feb, 2024 |
| Target Audience | 1. Regulatory Field Force. 2. Therapeutic Goods industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals |
| Problem Statement | The regulatory field force of Punjab has identified suspected samples of the following product in the market and sent them for analysis in the Drug Testing Laboratories. The Government Analyst has reported that these three products are falsified/spurious. The labelled stated manufacturer has informed that these samples are not manufactured and supplied by themselves in the market. |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No | Manufacturer (as per label) | |
| Duphaston 10mg Tablet | Dydrogesterone 10mg | 223298 | M/s. Highnoon Laboratories Ltd, 17-Km Multan Road, Lahore. |
| Femara 2.5mg Tablet | Letrozole 2.5mg | TTT60 | M/s. Novartis Pharma Stein AG SCHAFFHAUSERSTRASSE |
| Oxidil 1g Inj | Ceftriaxone 1g | 050K | M/s Healthtek Pvt Ltd, Karachi |
| Threat to Public Health | The use of these falsified products will result in the ineffective treatment of patients. Moreover, the safety and quality of the falsified products referenced in this alert are also unknown. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock to halt the distribution/supply of this product. Information related to the supplier of these product’s batches should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | Consumers should not use products bearing these batches and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product, 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. |