Safety Report: Dr. Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution - recalled due to decreased potency, USA

United States

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that it is voluntarily recalling six (6) 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. The issue was discovered during an accelerated stability test in addition to customer complaints. Sapropterin Dihydrochloride Powder for Oral Solution 100 mg was distributed nationwide to wholesalers/retailers. Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.

Reduced efficacy of the product would result in elevated Phenylalaninemia (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. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.

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 affected Sapropterin Dihydrochloride Powder for Oral Solution 100mg lots include the following:

- Product Name: Javygtor™ (Sapropterin) Dihydrochloride) Powder for Oral Solution 100 mg, Lot Number: T2202812; T2204053; T2300975; T2300976; T2304356, Expiration date: 07/2025; 10/2025; 02/2026; 02/2026; 08/2026, NDC Number: 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30

- Product Name: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, Lot Number: T2200352, Expiration date: 12/2024, NDC Number: 43598-477-30

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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Dr. Reddy’s Laboratories Inc
Brand name: Dr. Reddy’s
Product recalled: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
Reason of the recall: Decreased Potency
FDA Recall date: April 23, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg