Dr. Reddy’s Laboratories Ltd. is recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level.
According to the U.S. Food and Drug Administration, the recall was due to powder discoloration in some packets leading to decreased potency.
The product is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia or HPA due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).
Reduced efficacy of the product would result in elevated Phenylalaninemia or Phe levels in patients. Chronically elevated Phe levels in infants and children may cause permanent neurocognitive deficits, and elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.
The issue was discovered during an accelerated stability test in addition to customer complaints.
However, Dr. Reddy’s has not received any reports of adverse events related to the recall so far.
The impacted drug is packaged in individual packets, 30 per carton. The affected drugs include Javygtor Powder for Oral Solution 100 mg with lot mumbers T2202812, T2204053, T2300975, T2300976, and T2304356; as well as Sapropterin Dihydrochloride Powder for Oral Solution 100 mg with lot code T2200352.
The product was distributed nationwide to wholesalers/retailers.
Dr. Reddy’s is notifying its distributors and customers and is arranging for returns of all recalled products.
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