HSA suspends Zerin tablets

The tablets were found to have product defects and some tablets from different batches were found to contain small foreign particles.

The Health Sciences Authority is alerting members of the public to the suspension of the licence of Zerin tablets 500mg. Zerin tablets contain paracetamol, are manufactured by Jayson Pharmaceuticals Ltd and distributed in Singapore by Ziwell Medical Pte Ltd. Zerin tablets are used for the relief of fever and pain, and are available as an over-the counter medicine.

Although the health risk to the individual consumer is low, HSA is suspending Zerin tablets due to product defects recently found with this product. This is to prevent the exposure of members of the public to a product that is not compliant to quality standards. All sales and distribution of Zerin tablets have been discontinued from the public healthcare institutions, private medical clinics and pharmacies.

From HSA’s ongoing post marketing surveillance, four reports of product defects were investigated since August 2011 regarding Zerin tablets, where some tablets from different batches were found to contain small foreign particles.

Testing by HSA’s laboratories has shown that the foreign particles are inert, non-toxic substances and assessed to pose minimal risk to consumers. Tests also showed that the paracetamol content in Zerin tablets complies with registered specifications.

HSA’s Actions
After the initial reports of product defects, and as a precautionary measure, HSA has suspended the sales and distribution of Zerin tablets since August 2011.

HSA is currently working with Ziwell Medical Pte Ltd and Jayson Pharmaceuticals Ltd to ascertain the cause of the product defects in Zerin tablets. This includes a planned on-site audit of the manufacturer to assess its facilities and processes, including the review of possible root causes for the quality defects, as well as any corrective and preventive actions taken to address the root causes.

HSA has also worked with the relevant drug companies and healthcare providers to ensure that there are sufficient supplies of other brands of paracetamol to meet national needs.

As an added precaution, HSA had suspended the local licences of all products manufactured by Jayson Pharmaceuticals Ltd. Besides Zerin tablets, the other product marketed in Singapore is Histacin (chlorpheniramine) 4mg tablets, an antihistamine. The suspension of licence will disallow further sales of Histacin.

Consumer Advisory
Consumers who have stocks of Zerin tablets are advised to stop consuming the product. Consumers who have already taken the affected product should not be unduly alarmed as the product defect has been assessed to pose minimal risk to health.

Consumers who require paracetamol are advised to use any of the more than ten alternative brands of paracetamol tablets available in Singapore. Alternatively, they could also seek the advice of their healthcare providers.