Rapid Alert
| DRAP Alert No | No I/S/02-25-25 |
| Action Date | 27th February, 2025 |
| Target Audience | 1. Regulatory Field Force. 2. Therapeutic Goods Industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals |
| Problem Statement | The Federal Government Analyst, CDL, Karachi has notified the Drug Regulatory Authority of Pakistan that samples of the following products, seized by Customs, have been declared ‘Unregistered’ (falsified). The labels of these samples claim ‘Tramadol hydrochloride’ which has been confirmed by the test reports. Moreover, the labels do not provide any information regarding the manufacturer. The details of the reports are as below: |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Tramaking 225 Tablets | TM-044 | 03-2023 | 03-2026 | – | Un-Registered (Falsified) |
| New Tramadol 225 Tablets | TRD2015 | 02-2022 | 02-2027 | – | Un-Registered (Falsified) |
| TramaKing 250 Capsule | TKC2001 | 03-2022 | 03-2027 | – | Un-Registered (Falsified) |
| New Royal 225mg Tablets | TM-037 | 04-2023 | 04-2026 | – | Un-Registered (Falsified) |
| Tamral-250 Tablets | 243 | NIL | 03-2026 | – | Un-Registered (Falsified) |
| Tramaking Mega 225 Tablets | TRD2002 | 05-2022 | 05-2027 | – | Un-Registered (Falsified) |
| TramaKing 250 Tablets | TRK2001 | 03-2022 | 03-2027 | – | Un-Registered (Falsified) |
| Risk Statement | Falsified products having no identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. 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, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation. |
| 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. |