Rapid Alert
| DRAP Alert No | No I/S/03-25-28 |
| Action Date | 5th March, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Directorate of Drug Control Punjab (DDCP) has informed the Drug Regulatory Authority of Pakistan that the samples of the below mentioned products have been declared ‘Spurious’. |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Syrup Carenol 60mL Each 5ml contains: Ammonium chloride 125mg, Sodium Citrate 55mg, Chlorpheniramine maleate 2.5mg Reg. No. 026907 | CL-036 | Purported to be manufactured by Well Care Pharmaceuticals, A/7, P.S.I.E. Sargodha-Pakistan. | ‘Spurious’ as per Drugs Act 1976, section 3(z-b) (i) and ‘Misbranded’ as per section 39(s)(vi). | ||
| Powder for Inj. 2Sum 2g Sterile powder of Cefoperazone sodium eq. to Cefoperazone 1g, Sterile powder for sulbactam sodium eq. to Sulbactum 1g per vial Reg. No. 071447 | APK072 | Purported to be manufactured by Healthtek (Pvt) Ltd, Plot No. 14, Sector 19, Korangi Industrial Area Karachi -Pakistan. | Spurious’ as per Drugs Act 1976, section 3(z-b) (i) & (ii) and ‘Adulterated’ as per section 3(s)(iv) and ‘Substandard’ on the basis of Sterility. |
| Risk Statement | Falsified products having no active ingredient or 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. |