Dr Reddy’s recalls 6 lots of Sapropterin Dihydrochloride Powder

HyderabadDr. Reddy’s Laboratories is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency. 

Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date. The product is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU) and is packaged in individual packets, 30 per carton,’‘ the company informed the BSE.

It was discovered during an accelerated stability test in addition to customer complaints. Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients, it added. 

Potential health risks

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,’‘ the Hyderabad-based company informed the BSE. 

Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease. 

Dr. Reddy’s Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns of all recalled products.

 Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. 

”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. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase,’‘ it added. 

”Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.  This recall is being conducted with the knowledge of the U.S. Food and Drug Administration,’‘ the company said. 

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