Bharat Biotech recalls batch of typhoid vaccine after CDSCO red flag

TYPBAR is a preventive vaccine against typhoid fever (Representative image)

Hyderabad-based Bharat Biotech on June 8 said the company has recalled a batch of its typhoid vaccine after the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services flagged it as ‘Not of Standard Quality' (NSQ).

“Bharat Biotech has initiated a recall of TYPBAR batch # 54A22001A (vi polysaccharide typhoid vaccine) and communicated the same to the distribution chain,” Bharat Biotech said in a response to a query sent by Moneycontrol.

The company’s response came after the CDSCO officials found that the levels of O-acetyl levels that ‘did not comply with the specification’ in a batch manufactured from Hyderabad facility of Bharat Biotech.

The statement also said that there were no reports of adverse events or safety issues due to this batch in the country.

“The recall was initiated utilising the principle of abundant precaution based on test results of field samples by Central Drugs Laboratory,” the statement added.

According to an alert by CDSCO, the samples of the vaccine by Bharat Biotech were drawn by the Food and Drug Administration (FDA), Goa and were tested by Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh.

The TYBPAR typhoid vaccine from Bharat Biotech is the first vaccine in India to get a World Health Organisation Good Manufacturing Practice (WHO-GMP) prequalification certificate and is currently sold in more than 50 countries, according to the company.