Rapid Alert
| DRAP Alert No | No I/S/09-24-31 |
| Action Date | 06th 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 the identified products are as under: –
| S# | Product Name | Composition | Batch No. | Manufactured by (as stated on the label) | Test Results |
| 01 | Ativan 2mg Tablets | Lorazepam | 17C7019 | Purported to be manufactured by M/s. Pfizer Pakistan, Karachi | Spurious |
| 02 | Marfix 400mg Tablet | Cefixime | MK-0002 | M/s. Mirak Pharmaceutical, Lahore | Spurious |
| 03 | Payodine 10g/100ml Solution | Povidone-Iodine | 002709 | M/s. A.Mannan Lab, Karachi | Spurious |
| 04 | Froxime 400mg Capsule | Cefixime | FRX-400/C-6 | M/s. Froxx Pharmaceuticals, Karachi | Spurious & Misbranded |
| 05 | Noa-Xime 400mg Capsule | Cefixime | nx-00525-02 | M/s. Noa Hemis Pharmaceuticals, Karachi | Spurious & Misbranded |
| 06 | Biovim Injection | Benzyl Penicillin 500000 IU, Procaine Penicillin 1500000 IU | C. B-86 | M/s. Uniline Pharma, Karachi | Spurious |
| 07 | Novazone Plus Drench | Oxyclonazde 3% w/v, Levamisole HCl1.5% w/v, Cobalt Sulphate 0.075% /v, Selenium Selenite 0.035% | 061 | M/s. Uniline Pharma, Karachi | Spurious |
| 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 are 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 these products. |
| 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. |