Dr Reddy’s initiates voluntary recall of Sapropterin Dihydrochloride in US over potency concerns

Hyderabad: Dr Reddy's Laboratories Ltd on Tuesday informed the bourses that it has initiated a voluntary recall of six lots of Sapropterin Dihydrochloride powder for oral solution 100 mg in the US market.

The company said that though it has not received any reports of adverse events related to the recalled product till date, it had initiated the recall after it found powder discolouration in some packets, which could impact the medicine’s potency.

The discolouration was noticed during an accelerated stability test as well as after customer complaints, the company said.

Sapropterin Dihydrochloride is used for lowering blood phenylalanine (Phe) levels in adult and pediatric patients aged one month and older suffering from hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).

A reduction in the potency or efficacy of the drug could result in elevated Phe levels in patients, it said, adding that chronically elevated Phe levels in infants and children could cause permanent neurocognitive deficits and high levels during pregnancy were linked to microcephaly and congenital heart disease.

Dr Reddy’s said the affected lots of the drug were distributed nationwide to wholesalers and retailers and its US arm Dr Reddy’s Laboratories Inc, is notifying its distributors and customers through recall notification letters and is arranging for returns of all recalled products.