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Sun Pharmaceutical Industries has recalled 200 vials of cancer drug Gemcitabine for injection from the US market for lack of assurance of sterility.
Sun Pharma’s US subsidiary Caraco Pharmaceutical Laboratories initiated the voluntary recall on April 9, the US Food and Drug Administration (FDA) said in an enforcement report for the week of July 2.
The vials were manufactured by Sun Pharmaceutical Industries, it added.
The firm-initiated class II recall, which is ongoing, is due to “lack of assurance of sterility: a particle excursion for a different batch of the same product may lead to a lack of sterility assurance,” the FDA said.
According to the US health regulator, a class II recall is given in a situation when the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Shares of Sun Pharma closed at Rs 706.35 on the BSE, up 1.79 per cent.
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