The Drug Regulatory Authority Pakistan (DRAP) has banned the supply and sale of two drugs Flagyl Injection and Mirzpan Suspension 100mg/5ml following its recall alert.
In a “Rapid Alert” issued by DRAP, it was confirmed that the Mirzpan Suspension 100mg/5ml, bearing registration number 0326422 and batch number 007, was found to be spurious and unregistered.
The product, which was reportedly manufactured by M/s. Miraz Pharma, Qasoor Industries in Kasur, has been declared as a counterfeit by the Drug Testing Laboratory in Quetta.
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According to the DRAP, that Secretary PCQB Balochistan informed authority that Mirzpan Suspension 100mg / 5ml, Reg. No. 0326422 contains batch no 007, Purportedly Manufactured by M/s. Miraz Pharma, Qasoor Industries, Kasur, has been declared spurious, unregistered and misbranded by the Drug Testing Laboratory, Quetta.
It was further reported that the medicine contains no Active Pharmaceutical Ingredient (Cefixime), bears a fake registration number in seven digits, and exhibit a pH value of 6.51, which is outside the USP specified range of 2.5 to 4.5.
Additionally, the outer packaging of said batch contains multiple spelling errors, as well as ambiguous and misleading information.
In the light of report, DRAP has declared batch number 007 of Mirzpan to be spurious, prohibited its use and has banned the supply and sale of Mirzpan Suspension 100 mg.
DRAP in its “Risk Statement” also warned that the presence of counterfeit cefixime suspension poses significant risks to patient health, including potential therapeutic failure, inadequate treatment of bacterial infections, and the development of antibiotic resistance.
In a separate alert, DRAP has also declared batch number AD 482 of Flagyl Injectable 10ml, manufactured by M/s. Sanofi Aventis Pakistan Limited, Karachi, as substandard.
According to DRAP, Senior Drug Inspector ICT Islamabad has reported that Flagyl injection manufactured by M/s. Sanofi Aventis Pakistan Limited, Karachi has been reported as sub-standard by the drug testing laboratory Rawalpindi.
The regulatory authority has urged provincial drug control departments and regulatory field forces to conduct immediate market surveys to remove the substandard product from pharmacies. DRAP also instructed pharmacists and chemists to immediately stop supplying these products and quarantine any remaining stocks.
