Rapid Alert
DRAP Alert No | No I/S/01-25-01 |
Action Date | 2nd January, 2025 |
Target Audience | 1· National Regulatory Field Force of DRAP and Provincial Drug Control Departments 2· Healthcare Professionals (Physicians, Pharmacists & Nurses) 3. General Public |
Problem Statement | Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples various products have been identified as spurious (falsified). Details of test reports are as under: |
The product identification details are as under:
Therapeutic goods affected:
Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
Injection Penbiotic (Procaine Penicillin 1500000IU, Benzyl Penicillin 500000IU, Streptomycin Sulphate 5g) Reg# 0221448 | V044B23 | – | – | Purported to be manufactured by Nawan Laboratories, Karachi | Substandard & Spurious |
Orthoplast Plaster of Paris bandage 10cm x 2.7cm Reg# MDME-0000149 | 03E24 | – | – | Purported to be manufactured by Cotton Craft (Pvt.) Ltd., Lahore | Spurious |
Suspension Carfen 90ml (Ibuprofen 100mg/5ml) Reg# 066500 | CN-035 | – | – | Purported to be manufactured by Well care Pharmaceuticals Sargodha | Spurious & Misbranded |
Novidat tablet 500,g (Ciprofloxacin 500mg) Reg# 011837 | FIM063 | – | – | Purported to be manufactured by Sami Pharmaceuticals Karachi | 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 at 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. |