Rapid Alert
| DRAP Alert No | No I/S/09-24-35 |
| Action Date | 24th September 2024 |
| Target Audience | · Regulatory Field Force. · Healthcare Professionals – Physicians, Pharmacists, and Nurses. · Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions · General Public. |
| Problem Statement | The Directorate of Drugs Control (DDC) Punjab has detected the following falsified drug products based on their analysis from Drug Testing Laboratories (DTLs).The details of identified products and their batch details are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label) | Test Results |
| 01 | Solveron 10mg Tablets | Dydrogesterone 10mg | SVN-001 | M/s. Solvay, Plot# 32, Sector 2, Highway Petaro Road, Jamshoro. | Spurious |
| 02 | Carenol Syrup 450ml | Ammonium chloride 125mg/5ml, Sodium Citrate 55mg/5ml, Chlorphenramine Maleate 2.5mg/5ml | CL-012 | M/s. Well Care Pharmaceuticals, A/7 P.S.I.E. Sargodha. | Spurious and Misbranded |
| 03 | Procain Penicillin Fort 4000000 I.U. Injection | Procaine Penicillin 3000000 I.U., Benzyl Penicillin 1000000 I.U | 140475 | M/s. Yanzhou Xier Kangtai Pharm. Co. Ltd., China. Sole agent: United International, 301 Madian Center, Plot No. MR-1/122, 3rd Floor, Kutchi Gali No. 2, Marriot Road, Karachi. | Spurious |
| 04 | Simgesic Tablet | Tramadol HCl 37.5mg, Paracetamol 325mg | B1985 | M/s. Siam Pharmaceutical, Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad. | Spurious and Misbranded |
| 05 | Meronem 500mg Injection | Meropenem 500mg | 4B23D121 | ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi. | Spurious and Substandard |
| 06 | Meronem 1g Injection | Meropenem 1gm | 4A23A31 | ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi. | Spurious and Substandard |
| Threat to Public Health | Spurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert is 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 this product 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 stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and 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. |