Rapid Alert: Presence of Falsified Mirzpan Suspension 100mg/5ml Purportedly Manufactured by M/s. Miraz Pharma, Kasur.

Rapid Alert

DRAP Alert NoNo  I/S/01-25-12
Action Date23rd January, 2025
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementSecretary, PQCB Balochistan, has informed DRAP that sample of following product, manufactured by M/s Miraz Pharma, Kasur, has been declared “Spurious”, “Unregistered” and “Misbranded” by the Drug Testing Laboratory, Quetta. The sample portion “Suspension Mirzpan” 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 – 4.5. Additionally, the outer packaging contains multiple spelling errors, as well as ambiguous and misleading information. The details of sample are as under::

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)
Remarks
Mirzpan Suspension 100mg / 5ml
 
Reg. No. 0326422
00711-202311-2025Purported to be manufactured by M/s Miraz Pharma, Plot No. 23, Qasoor Industries, Kasur.Spurious

Risk Statement:The presence of falsified cefixime suspension poses significant risks to patient health, including potential therapeutic failure, inadequate treatment of bacterial infections, and the development of antibiotic resistance.
Action InitiatedThe field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available at this link.
Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.