Action Taken:

The manufacturer has been directed by DRAP to immediately recall the defected batch of product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).

Details of the Affected Product:

Product Name

Novarise

50mg/5mL

Syrup

Composition

Iron (iii)

Hydroxide

Polymaltose

complex

Batch number

Batch No. 113

Manufactured by

M/s

Sharooq

Pharmaceuticals (Pvt.)

Ltd., Lahore

Remarks

The analysis

revealed 0.7818%

ethylene glycol,

which does not

comply.


Risk Assessment:

The presence of Ethylene Glycol (EG) in oral liquid preparations poses serious health risks due to its toxicity as small amounts of EG can be fatal, especially for children. When ingested, both diethylene glycol (DEG) and EG are metabolized into toxic compounds that can adversely affect the central nervous system, heart, and kidneys.


Advice for General Public and Consumers:

Consumers should stop using this product if it has the affected batch number. If they have experienced any problems after using this drug, they should contact their doctor for advice. Additionally, it's important to report any issues to the Drug Regulatory Authority of Pakistan or the National Pharmacovigilance Centre so they can investigate and take necessary action..