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 official sources.
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.
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