HYDERABAD: Dr Reddy’s Laboratories Ltd on Tuesday knowledgeable the bourses that it has initiated a voluntary recall of six tons of Sapropterin Dihydrochloride powder for oral resolution 100 mg in the US market.
The firm stated that although it has not obtained any experiences of adversarial occasions associated to the recalled product until date, it had initiated the recall after it discovered powder discolouration in some packets, which may impression the drugs’s potency.
The discolouration was seen throughout an accelerated stability take a look at in addition to after buyer complaints, the corporate stated.
Sapropterin Dihydrochloride is used for decreasing blood phenylalanine (Phe) ranges in grownup and pediatric sufferers aged one month and older affected by hyperphenylalaninemia (HPA) as a consequence of tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).
A discount in the potency or efficacy of the drug may consequence in elevated Phe ranges in sufferers, it stated, including that chronically elevated Phe ranges in infants and youngsters may trigger everlasting neurocognitive deficits and excessive ranges throughout being pregnant had been linked to microcephaly and congenital coronary heart illness.
Dr Reddy’s stated the affected tons of the drug had been distributed nationwide to wholesalers and retailers and its US arm Dr Reddy’s Laboratories Inc, is notifying its distributors and clients by recall notification letters and is arranging for returns of all recalled merchandise.
The firm stated that although it has not obtained any experiences of adversarial occasions associated to the recalled product until date, it had initiated the recall after it discovered powder discolouration in some packets, which may impression the drugs’s potency.
The discolouration was seen throughout an accelerated stability take a look at in addition to after buyer complaints, the corporate stated.
Sapropterin Dihydrochloride is used for decreasing blood phenylalanine (Phe) ranges in grownup and pediatric sufferers aged one month and older affected by hyperphenylalaninemia (HPA) as a consequence of tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).
A discount in the potency or efficacy of the drug may consequence in elevated Phe ranges in sufferers, it stated, including that chronically elevated Phe ranges in infants and youngsters may trigger everlasting neurocognitive deficits and excessive ranges throughout being pregnant had been linked to microcephaly and congenital coronary heart illness.
Dr Reddy’s stated the affected tons of the drug had been distributed nationwide to wholesalers and retailers and its US arm Dr Reddy’s Laboratories Inc, is notifying its distributors and clients by recall notification letters and is arranging for returns of all recalled merchandise.
