Rapid Alert
| DRAP Alert No | No I/S/11-24-44 |
| Action Date | 08th November, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | The Directorate of Drugs Control (DDC) Punjab has identified the following falsified products in the market. The samples of these products were also analyzed by provincial Drug Testing Laboratories in Punjab. The details of the identified products are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | Ativan 2mg Tablets Reg# 000084 | Lorazepam | 17C7019 | Purported to be manufactured by Pfizer Pakistan Ltd, Karachi Pakistan | Spurious |
| 2 | Klozen 5 mL Eye Drops Reg# 040124 | Tobramycin 0.3%, Dexamethasone 0.1% | 134 | Purported to be manufactured by Zinta Pharmaceutical Industry, Hayatabad, Peshawar | Spurious |
| 3 | S-Kyne 10mg Tablets Reg# Nil | Dydrogesterone | 566 | Purported to be manufactured by Weather Folds pharmaceuticals, Hattar | Spurious & Misbranded |
| 4 | Efaston 10mg Tablets Reg# 31067 | Dydrogesterone | 064835 | Purported to be Manufactured by Lahore Chemical & Pharmaceutical Works (Pvt) Ltd. Lahore | Spurious |
| 5 | Dydowen 10mg Tablets Reg# 101507 | Dydrogesterone | 462 | Purported to be Manufactured by Weather Folds Pharmaceuticals, Hattar | Spurious |
| 6 | Phenobar 30mg Tablets Reg# 018862 | Phenobarbitone | QA030 | Purported to be Manufactured by Star Laboratories (Pvt) Ltd (Human Healthcare Division) 23-KM Multan Road Lahore | Spurious |
| 7 | Duphaston 10mg Tablets Reg# 006654 | Dydrogesterone | 230672 | Purported to be Manufactured by Highnoon Laboratories Ltd. Marketed by Abbot Laboratories (Pakistan) Ltd, Lahore | Spurious |
| Risk Statement: | The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems. |
| Action Initiated | The field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market. |
| 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 on 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.