Flagged by the Central Drugs Standard Control Organisation (CDSCO) as “not of standard quality’’, Hyderabad-based Bharat Biotech on June 8 confirmed that it had recalled a batch of its typhoid vaccine.
CDSCO officials found that a batch manufactured at the Hyderabad facility did not comply with the standard specification of the drug controller. While the company in its statement, said that there were no reports of adverse events or safety issues due to the batch in the country, it added that a recall had been initiated.
“Bharat Biotech has initiated a recall of TYPBAR batch 54A22001A (vi polysaccharide typhoid vaccine) and communicated the same to the distribution chain,” a Bharat Biotech statement said.