Bharat Biotech on Thursday 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).
In the batch manufactured by the Hyderabad-based firm, the CDSCO officials said the levels of O-acetyl did not comply with the specification, according to a report by Moneycontrol.
“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 Moneycontrol.
In a statement by Bharat Biotech, it added that the recall was initiated utilising the principle of abundant precaution based on test results of field samples by the Central Drugs Laboratory.
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 tested by the Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh.
Bharat Biotech's TYBPAR vaccine is the first in India to receive the World Health Organisation Good Manufacturing Practice (WHO-GMP) prequalification certificate and is currently sold in more than 50 countries, according to the company.