Rapid Alert; Drug Product: Falsified Ciproxin 500mg Tablets identified in the Market

Rapid Alert

Falsified Ciproxin 500mg Tablets

DRAP Alert NoNo  II/S/06-23-28
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementProvincial Drug Control team has seized suspected falsified Ciproxin 500mg Tablets during the market surveillance activities in the District Kasur, Punjab. The Manufacturing Authorization holder company i.e. M/s Bayer Pakistan (Pvt) Ltd, Karachi has stated that based on the physical verification of security features, the products seized are not genuine, and thus it is a spurious/falsified products.

The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
1Ciproxin 500mg Tablets

Mfg.Date: 12-21
Exp.Date: 11-26
CiprofloxacinBAA928M/s.Novartis Pharma (Pakistan) Ltd, Karachi
For Bayer Pakistan (Pvt) Ltd, Lahore
Risk Statement:Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings:
-Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating.
-These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health.
-Poor-quality medicines compromise the treatment of diseases and may intensified the existing condition.
Action InitiatedThe 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 ConsumersConsumers 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.