Rapid Alert
| DRAP Alert No | No I/S/11-24-45 |
| Action Date | 08th November, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · Veterinary Healthcare Professionals · General Public |
| Problem Statement | Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples following products have been analyzed by the provincial DTLs in Punjab and have been declared as substandard due to reasons mentioned below. The detail of affected products is as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by | Test Results |
| 01 | Nida Infusion 100ml Reg. No. 079630 | Metronidazole 500mg/100ml | 23E317 | GMP Pharmaceuticals, 28-Km Sheikhupura Road, Lahore. | Substandard due to visible particles and Bacterial Endotoxin. |
| 02 | Metroin Infusion 100ml Reg. No. 071279 | Metronidazole 500mg/100ml | MT24-055 | Saturn Pharmaceuticals, 23-Km, thokar Raiwind Road, Lahore | Substandard due to presence of visible particles. |
| 03 | Tylosan 20 Injection 100ml Reg. No. 027416 (For vet use only) | Tylosin base 200mg/ml | TS-259 | Sanna Laboratories, 1019-B, P.I.S.E., Sargodha road, Faisalabad. | Substandard due to presence of visible particles. |
| 04 | Melacam-10 injection 50ml Reg. No. 063542 (For vet use only) | Meloxicam 10mg/ml | 23U-03 | Medi-vet (Pvt) Ltd., 17-Km Sheikhupura road, Lahore | Substandard on the basis of visible particles and extractable volume. |
| Threat to Public Health | Administration of products containing visible solid particles and/or bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences. |
| Action Initiated | The manufacturing companies of these products have been directed to immediately recall the affected batches of their products from the market. The Regulatory Field Force of DRAP and Provincial Drug Control Administrations have been directed to conduct market surveys for monitoring the recall process to ensure effective removal of defective batches from the market. All Pharmacists and Chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should have increased surveillance in the market to ensure the effective recall of defective products(s). |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link. 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 Consumer | 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 these 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.