Falsified and Unregistered Paracetol 500mg Tablets
|DRAP Alert No||NoI/S/ 02-20-09|
|Action Date||6th April, 2023|
|Target Audience||1. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores|
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
3. General Public
|Problem Statement||Drug inspector Diamer/Astore took the sample of Paracetol 500mg Tablets (Bach No. 470) and sent it to Drug Water and Food Testing Laboratory, GB, for test/analysis, which has been declared as a counterfeit product.|
The product detail as mentioned on the label is as under: –
Therapeutic Goods Affected:-
|Sr||Product Name||Composition||Batch #||Manufactured by||Remarks by Laboratory|
|1||Paracetol 500mg Tablets |
Mfg. Date: 11-2022
Exp. date: 11-2024
|Paracetamol||470||Ms. Roryan Pharmaceuticals (Pvt.) Ltd., Peshawar.||The sample is Counterfeit under the Drugs Act 1976 as it resembles with Panadol 500mg Tablets by M/s GSK.|
The Product has also been declared Un-Registered By DRAP*.
|Risk Statement:||Paracetamol is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains, and general aches and pains. It is also used to help reduce fever. Unregistered/falsified products may lead to adverse reactions including but not limited to the following:|
· Blood disorders, such as thrombocytopenia and leukopenia.
· Liver and kidney damage.
· Sub-therapeutic effect regarding fever, inflammation, and pain control.
|Action Initiated||The manufacturer has been directed to immediately recall this product from the market. The Regulatory Field Force has been directed to increase surveillance throughout the supply chain. 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 supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.|
|Advice for Healthcare Professionals||-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned product(s).|
-Adverse reactions 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 this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.