Discoloration Leads to Recall of Sapropterin Products

Dr. Reddy's Laboratories is recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to powder discoloration in some packets. This could lead to decreased potency. The issue was discovered because of customer complaints and from accelerated stability test.

Sapropterin Dihydrochloride is used to treat adult and pediatric patients one month of age and older with the metabolic disorder hyperphenylalaninemia (HPA) that is the result of tetrahydrobiopterin-responsive Phenylketonuria (PKU). It is indicated to reduce the level of phenylalanine (Phe) in the blood.

Hyperphenylalaninemia is an abnormal increase in the amino acid phenylalanine in the blood. High concentrations of phenylalanine can lead to Phenylketonuria, a condition where there is decreased activity of a liver enzyme called phenylalanine hydroxylase. Untreated, the condition can lead to microcephaly, delayed or absent speech, seizures, eczema, and behavioral issues.

Lowered potency of Sapropterin Dihydrochloride could result in elevated phenylalaninemia levels in patients. Chronically elevated Phe levels in infants and children can cause permanent neurologic deficits.

The recall affects five lots of the branded product Javygtor and one lot of the generic product sapropterin. The products are packaged in individual packets with 30 per carton. NDC and lot numbers of the affected products can be found here.

Javygtor was developed by Cycle Pharmaceuticals, which partnered with Dr. Reddy’s for distribution. Javygtor was launched in October 2022.