Dr. Reddy’s Laboratories recalls sapropterin dihydrochloride powder in the US

Dr. Reddy’s Laboratories Ltd and its subsidiaries have issued a voluntary recall of six lots of sapropterin dihydrochloride powder for oral solution 100 mg in the US due to discolouration in some packets, which could reduce potency. The issue was discovered during an accelerated stability test and following customer complaints. 

The company said the product is used to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive phenylketonuria (PKU). The reduced efficacy of the product could lead to elevated Phe levels, potentially causing permanent neurocognitive deficits, developmental delay, and seizures in infants and children. Elevated Phe levels during pregnancy are associated with microcephaly and congenital heart disease. 

The company also said it has not received any reports of adverse events related to the recall to date. The affected lots were distributed to wholesalers and retailers. The company is notifying its distributors and customers through letters and is arranging for the return of all recalled products, it said. 

The shares were up by 0.31% to ₹5,972.30 at 1.35 pm on the BSE.