Dr. Reddy's Laboratories recalls six lots of sapropterin dihydrochloride due to discolouration, impacting potency in treating PKU patients.
Dr. Reddy's Laboratories recalls six lots of sapropterin dihydrochloride powder for oral solution 100mg 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 drug is used to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin-(BH4-) responsive phenylketonuria (PKU), and reduced efficacy could lead to elevated phenylalanine levels, potentially causing permanent neurocognitive deficits, developmental delay, and seizures in infants and children. The company has not received any reports of adverse events related to the recall.
April 23, 2024
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