Dr. Reddy’s Laboratories Ltd on Tuesday announced that it is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg in the U.S. due to powder discoloration in some packets, leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.
As per a release from the pharmaceutical company, reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.
Dr. Reddy’s said its subsidiary Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately, the drugmaker said.
Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, which is being recalled, should contact their physician before stopping use of the product, the company added. Consumers have also been asked to return the product to their place of purchase.
