Rapid Alert
| DRAP Alert No | No I/S/06-24-27 |
| Action Date | 14th June 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 vide Alert No. 137/2024 has informed that the following samples of drug products have been declared as “Spurious” by Drug Testing Laboratories (DTL) Multan, Lahore, Rawalpindi, and Faisalabad. Details of affected products are as follows:. |
The details of affected products and their batches are as under: –
| S# | Product Name | Batch No. | Purported to be Manufactured by (as per label) | Batch No. |
| 01 | Powder Amox 500 (1kg) (veterinary use) | 0010823 | Imported by: M/s. Brand Station, Lahore. Mfg. by: M/s. The North Star Import Export Joint Stock Company, Can Tho City, Vietnam. | Spurious |
| 02 | Nutricare Syrup 450ml | NC-457 | M/s. Care Pharmaceuticals. | Spurious |
| 03 | Velosef 500mg Capsule | 847M | M/s. GSK, Karachi. | Spurious |
| 04 | Pyodine Solution 60ml | 04813 | M/s. Brookes Pharma, Karachi. | Spurious |
| 05 | Pyodine Solution 450ml | 08913 | M/s. Brookes Pharma, Karachi. | Spurious |
| 06 | Tanzo 0.5g Injection | PN220142 | M/s. Bosch Pharmaceuticals, Karachi. | Spurious |
| 07 | Dydowen 10mg Tablet | 736 | M/s. Weather Fold Pharmaceuticals, Hattar. | Spurious |
| 08 | Duphaston 10mg Tablet | 230672 230092 | Mfg. by: Highnoon Laboratories Lahore. Mfg for: Abbott Laboratories, Karachi. | Spurious |
| 09 | Cefspan 400mg Capsule | D6780 | M/s. Barrett Hodgson Pakistan, Karachi. | Spurious |
| 10 | Phenobar 30mg Tablet | QA023 | M/s. Star Laboratories, Lahore. | 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 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. |