The issue was discovered during an accelerated stability test in addition to customer complaints, it added. Reduced efficacy of the product would result in elevated 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.
Dr Reddy’s Laboratories Inc, the US-based arm of the company, has not received any reports of adverse events related to this recall to date, the company said.
Dr Reddy’s Laboratories Inc is notifying its distributors and customers by recall notification letters and arranging for returns of all recalled products, it said.
Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately, it added. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg from the affected lot should return it to their place of purchase, the company said.
