Islamabad : Jan 28 : The Drug Regulatory Authority (DRAP) has ordered recalling of INCIP 200mg INFUSION (Batch #CPV-85)
(Manufactured by M/S. INVENTOR PHARMA PVT. LTD., KARACHI, citing it as a substandard product. DRAP alert issued the following alert here on January ,16 .
Target Audience:
1 Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2: Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
3: General Public
Alert Summary:
Federal Government Analyst, CDL Karachi has declared the Batch No. 065 of product “INCIP Infusion” as
of Substandard quality.
Details of the affected product is as under:
Product Name Composition Batch Details Manufactured by Remarks
INCIP 200mg
Infusion
Reg.No 088363
Ciprofloxacin Batch No. CPV-85
Mfg. Date: 09-23
Exp. date: 09-25
M/s Inventor Pharma
(Pvt) Ltd, Karachi
The sample is of
Sub-standard quality
(on basis of visible
particulate matter).
Risk Assessment: –
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.
Action Initiated: –
The manufacturer has been directed 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 products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of DRAP and Provincial Health Departments has increased surveillance in the market to ensure the effective recall of defective products.