ISLAMABAD: The Drug Regulatory Authority Pakistan (DRAP) has recalled INCIP 200mg Infusion (Ciprofloxacin) Batch No CPV-85 manufactured by Inventor Pharma (Pvt) Ltd as the product was declared substandard by Central Drugs Laboratory (CDL) Karachi.
A recall alert issued here by DRAP said federal government analyst CDL Karachi has declared Batch No 065 of product “INCIP Infusion” as of substandard quality, therefore, all the concerned quarters are directed to stop using the product with immediate effect. Ciprofloxacin Usp 200mg Infusion is a versatile antibiotic medicine that can be used to treat many different infections caused by bacteria.
The regulator has advised pharmacists and chemists at distribution, pharmacies and medical stores, healthcare professionals-physicians, pharmacists, nurses at hospital and clinics and the general public to avoid using the aforementioned product with immediate effect.
The regulator warned, “the impact of the use of substandard infusion on the basis of visible particulate matter may introduce contaminants into the bloodstream that lead to adverse reactions or sepsis”.
Following the development, the DRAP has directed the manufacturer to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of the product.
The remaining stock should be quarantined and returned to the supplier/company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increased surveillance in the market to ensure the effective recall of defective products.
Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at [email protected].
The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
The DRAP has urged healthcare professionals to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.
Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre (NPC), DRAP using the Adverse Event Reporting Form or online.
Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.
Copyright Business Recorder, 2024
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