Dr. Reddy’s US Subsidiary Recalls Drug Quoting Efficacy Issues

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Synopsis:

 Dr Reddy’s Laboratories announces the voluntary recall of six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg in the US due to powder discolouration, leading to decreased potency. Elevated Phenylalaninemia (Phe) levels pose risks of permanent neurocognitive deficits. The company urges consumers to contact physicians and return affected lots promptly.

Dr Reddy’s Laboratories Ltd has initiated a voluntary recall of six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg in the U.S. This recall comes as a result of powder discolouration observed in some packets, leading to decreased potency of the medication.

Risk of Congenital Heart Disease

The reduced efficacy of the product poses a risk of elevated Phenylalaninemia (Phe) levels in patients. Chronic elevation of Phe levels, particularly in infants and children, is associated with permanent neurocognitive deficits such as intellectual disability, developmental delay, and seizures.

Moreover, elevated Phe levels during pregnancy, especially in early gestation, may lead to complications such as microcephaly and congenital heart disease.

Dr Reddy’s Lab Response and Recommendations

Dr Reddy’s Laboratories Inc., the US-based subsidiary, has not received any adverse event reports related to this recall. However, consumers are urged to examine their inventory of the affected product and quarantine any recalled lots immediately.

Additional Read: Share Market News

The company advises consumers to consult their physician before discontinuing the use of the medication. Additionally, consumers are instructed to return the recalled product to their place of purchase.

The recall underscores the importance of quality control in pharmaceutical products to ensure the safety and efficacy of medications for patients.

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