Contaminated batch of syrup found”coldContains acetaminophen and chlorphenamaleate reported by the Republic of Iraq World Health Organization (WHO). Although it may have marketing authorization in other countries or regions, and may have been distributed to other countries through the informal market, the data show.
Contaminated batch of “COLD OUT” syrup containing paracetamol and chlorpheniramine maleate discovered in the Republic of Iraq
A sample of “COLD OUT” syrup was obtained from somewhere in the above mentioned countries and submitted for laboratory analysis.The samples were found to contain unacceptable amount Diethylene glycol (0.25%) and ethylene glycol (2.1%) were used as pollutants. Diethylene glycol and ethylene glycol are toxic to humans and potentially fatal when ingested, and the acceptable safe limit for these two ingredients is no more than 0.10%.
A combined paracetamol and chlorpheniramine syrup is used to treat and Relieve symptoms From the common cold and allergies.
use of this contaminated product unsafe Its use, especially by children, may result in serious injury or death. Toxic effects may include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status and acute kidney injury that can lead to death.
The declared manufacturer of the affected batches is Foltz (India) Laboratory PVT. LTD, the product claims to be manufactured by Dabilife Pharma PVT. Ltd. – India.To date, declared manufacturers and marketers have not Guarantee provided Notify the World Health Organization of the safety and quality of the product.
Advice to regulators and the public
The World Health Organization advises against use of affected products, if any. “If you or someone you know has used or may have used Affected Productsor experience adverse or unexpected side effects after use, you are advised to see a health professional immediately,” insists the World Health Organization.
You have adverse reactions or unexpected side effects after use
Although this medical product alert concerns only one batch of products, out of an abundance of caution, WHO recommends increased monitoring and testing of the entire product.Therefore, the health sector United Nations Call for vigilance and diligence in supply chains in countries and regions that may be affected by these products.
Enhanced regulation of informal/unregulated markets is also recommended.Advice to national regulators and health authorities notify immediately Please inform the World Health Organization if these substandard products are found in the respective countries.
Manufacturers of syrups, especially those containing excipients such as Propylene Glycol, Polyethylene Glycol, Sorbitol, and/or Glycerin/Glycerin, check ethylene glycol and diethylene glycol for contaminants before using them in pharmaceuticals. Healthcare professionals should report any suspected cases of adverse reactions associated with the use of contaminated medicinal products to the national regulatory agency/National Center for Health. Pharmacovigilance.