Dr. Reddy's Laboratories Recalls Sapropterin Dihydrochloride Powder Due to Discoloration and Decreased Potency

Dr. Reddy's Laboratories Ltd, a pharmaceutical company based in Hyderabad, India, has voluntarily recalled six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg in the United States due to powder discoloration and decreased potency.

The issue was identified through accelerated stability testing and customer complaints. "The reduced efficacy of the product can lead to elevated Phenylalaninemia levels, which can cause severe neurocognitive deficits in infants and children, such as intellectual disability, developmental delays, and seizures," the company stated.

The recall is being conducted at the consumer level, and Dr. Reddy's Laboratories has not received any reports of adverse events related to this issue. The affected lots were distributed nationwide in the United States. Consumers who have the product should contact their physician before stopping use and return it to their place of purchase.

Why this matters: Sapropterin Dihydrochloride is a critical medication for managing Phenylketonuria (PKU), a rare genetic disorder that affects the body's ability to process the amino acid phenylalanine. The decreased potency of the recalled product could lead to serious health consequences for infants and children with PKU, emphasizing the significance of strict quality control measures in pharmaceutical manufacturing.

Dr. Reddy's Laboratories is actively communicating with its distributors and customers, advising them to inspect their stock and return any affected products. The company is urging consumers to inspect their supply and return any of the recalled lots to their place of purchase. "Dr. Reddy's is notifying its distributors and customers about the recall, and consumers can contact the company with any questions or report adverse events to the FDA," a company spokesperson said.

Key Takeaways

• Dr. Reddy's recalls 6 lots of Sapropterin Dihydrochloride Powder due to discoloration and subpotency.
• Reduced efficacy can lead to elevated Phenylalaninemia levels, causing severe health issues in infants and children.
• Recall is at the consumer level, and no adverse events have been reported so far.
• Sapropterin Dihydrochloride is a critical medication for managing Phenylketonuria (PKU).
• Dr. Reddy's is actively communicating with distributors and customers to return affected products.