Dr. Reddy's Laboratories recalls 6 lots of one of its drugs

24 Apr 2024 , 03:46 PM

Dr. Reddy's Laboratories Ltd. has initiated a voluntary recall of six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg. The reason behind the recall is the presence of powder discoloration in some packets, which can lead to a decrease in potency. The issue was identified during an accelerated stability test and subsequent customer complaints.

There is a risk associated with reduced potency, particularly in patients with Phenylketonuria (PKU), as it can result in elevated Phenylalaninemia (Phe) levels. Elevated Phe levels pose a significant health risk, especially in infants and children, as they can lead to permanent neurocognitive deficits.

Potential consequences include irreversible intellectual disability, developmental delays, and seizures. Moreover, elevated Phe levels during pregnancy, especially in early stages, are linked with adverse outcomes such as microcephaly and congenital heart disease.

Despite the recall, Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events associated with the affected product. The recalled product is primarily use for reducing blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-responsive PKU. It is packaged in individual packets, with each carton containing 30 packets.

Dr. Reddy’s Laboratories Inc. is actively communicating the recall to its distributors and customers through recall notification letters. They are facilitating the return of all recalled products to address the issue promptly. Those who possess the recalled product in their inventory are advised to inspect it immediately and quarantine any affected lots.

Consumers who have the recalled product should consult their physician before discontinuing its use to ensure proper management of their condition. Furthermore, consumers are urged to return the recalled product to the place of purchase for a refund or replacement.

If consumers have encountered any problems or adverse effects associated with the use of this drug product, they are encouraged to contact their healthcare provider for guidance and support.

This news hasn't affected the stock price majorly. At the time of writing stocks of DR. Reddy's were trading at ₹5949.60 which is a 0.42% dip than the previous close.

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