Falsified and Unregistered Sildenafil Citrate 100mg Tablets
|DRAP Alert No||NoI/S/02-23-18|
|Action Date||3rd May 2023|
|Target Audience||1. Regulatory Field Force|
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
|Problem Statement||Federal Inspector of Drugs Karachi seized a sample of an unregistered product “Viagra 100mg Tablet” from the market and also sent the samples to Central Drug Laboratory, Karachi for testing/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (i) of the Drugs Act 1976.|
The product detail as mentioned on the label is as under: –
Therapeutic Goods Affected:-
|Sr||Product Name||Composition as per label||Batch #||Manufactured by (as stated on label)|
|1||Viagra 100mg Tablets|
Mfg. Date: 03-2021
Exp. date: 03-2025
|Sildenafil Citrate||19990544AG||Ms. Brooklyn, Ne.|
|Risk Statement:||Consequences of the use of unregistered, Spurious/ Falsified Drugs include but are not limited to the followings:|
· Falsified/Spurious drugs may contain toxic ingredients which are manufactured under unhygienic conditions without the proper inspection and approval of the product, which are highly injurious to human health.
· Poor-quality medicines compromise the treatment of diseases and may intensify the existing condition.
|Action Initiated||The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. 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 above-mentioned products.|
-Adverse reactions or quality problems experienced with the use of these product 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.