A voluntary recall of 200 vials of the cancer drug Gemcitabine injection from the U.S. market was initiated by Sun Pharmaceutical Industries’ US subsidiary Caraco Pharmaceutical Laboratories on April 9, reported the US Food and Drug Administration (FDA) on July 2. According to the enforcement report the drug had been recalled due to lack of assurance of sterility. (Read: New drug could help revolutionize cancer treatment)
According to the FDA report 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. 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. (Read: Biocon’s affordable breast cancer drug Canmab launched)
The shares of Sun Pharma closed at Rs. 706.35 on the BSE, up 1.79 per cent.
Source: PTI
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