Rapid Alert
| DRAP Alert No | No I/S/12-23-46 |
| Action Date | 29th December, 2023 |
| Target Audience | 1. Regulatory Field Force. 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. Healthcare Professionals – Physicians, Pharmacists, and Nurses, Procurement officer at hospitals and institutions 4. General Public. |
| Problem Statement | On December 12, 2023, the regulatory field force in Karachi raided and shut down an illegal drug manufacturing facility. They collected product samples and sent them to the Central Drugs Laboratory (CDL) in Karachi for testing. The Federal Government Analyst at the CDL confirmed that the products seized by FID-III Karachi from the illicit site were “spurious”. The test results showed that these products lacked the stated active ingredients. There is a possibility that the fake manufacturers have infiltrated the supply chain with some of their falsified products. |
| Threats to Public Health | The use of falsified products will result in ineffective treatment. This may cause therapy failure which may lead to increased morbidity and also, mortality, in case of untreated infections. Moreover, the safety of these falsified products is also unknown. |
The product identification details are as under: –
Therapeutic Goods Affected*:-
| Product Name | Composition (as per label) | Batch / Lot | Mfg Date | Exp Date | Manufacture Name (as stated on label) | Illustrative Images |
|---|---|---|---|---|---|---|
| AL Coxime 400mg Capsule | Cefixime | 110 | 04-23 | 03-25 | M/s. Alpine Laboratories (Pvt) Ltd., Karachi | See DRAP Alert |
| Sinoxime 100mg/5ml Dry Suspension | Cefixime | 101S13 | 10-23 | 09-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Flox-G 500mg Tablet | Levofloxacin | 760 | 01-23 | 12-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Flox-G 250mg Tablet | Levofloxacin | 761 | 01-23 | 12-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Amcox 125mg/5ml Suspension | Amoxicillin | 23217 | 04-23 | 03-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Snagxone 1g injection | Ceftriaxone | L23-4 | 06-23 | 06-25 | M/s Leckman Laboratories Pvt Ltd., Karachi | |
| Leckzolid 600mg Tablets | Linezolid | 002 | — | 09-24 | M/s Leckman Laboratories Karachi | |
| Uniclav 156.25mg/5ml Suspension | Co-amoxiclav | 126 | 09-23 | 08-25 | M/s. Uni-Tiech Pharmaceutical Pvt Ltd., Karachi |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate/seize these falsified products without any delay. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and halt the distribution/supply of these falsified products. Information related to the supplier of these falsified products should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these falsified 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 these falsified products. -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 not use these falsified products and should contact their physician or healthcare provider if they have experienced any problem related to taking or using any of these falsified 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. |