Dr. Reddy's Laboratories Ltd. has issued a recall for six batches of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg. This recall is a response to concerns raised by the U.S. Food and Drug Administration (FDA) about discolouration in certain sachets that were resulting in reduced effectiveness.
The medication is designed to decrease the levels of phenylalanine, also known as Phe, in the blood. It is prescribed to both adult and pediatric patients, a month old and upwards, who have hyperphenylalaninemia or HPA — a condition that's responsive to tetrahydrobiopterin (BH4), associated with Phenylketonuria (PKU).
The cause for concern is that reduced efficacy could lead to elevated Phe levels in patients. Persistently high Phe levels in children and infants can lead to permanent neurocognitive damage. Meanwhile, elevated levels of Phe during early pregnancy are linked with conditions such as microcephaly and congenital heart disease.
This pressing issue came to light during an accelerated stability test, along with consumer complaints. However, Dr. Reddy's has not reported any adverse events linked with the recall thus far.
The drug is packaged into individual sachets, with 30 to a carton. Affected drugs include Javygtor Powder for Oral Solution 100 mg with the batch numbers T2202812, T2204053, T2300975, T2300976, and T2304356. Also affected is Sapropterin Dihydrochloride Powder for Oral Solution 100 mg with the batch number T2200352.
The medication in question was distributed nationwide to wholesalers and retailers. Dr. Reddy's Laboratories Ltd. is actively notifying customers and distributors regarding the recall and is making arrangements for the return of all recalled products. For further health news updates, visit rttnews.com.
