Why Dr. Reddy’s Sapropterin Dihydrochloride Powder Is Being Recalled

Dr. Reddy’s Laboratories Ltd. has initiated a voluntary nationwide recall of six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to discoloration in some packets, resulting in decreased potency. This issue, identified during an accelerated stability test and through customer complaints, poses a risk of reduced efficacy, potentially leading to elevated Phenylalaninemia (Phe) levels in patients.

Risk Explanation: Elevated Phe levels, especially in infants, children, and pregnant individuals, may cause permanent neurocognitive deficits, developmental delay, seizures, microcephaly, and congenital heart disease. As of now, Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall.

Affected Product Details:

Product Name: Javygtor™ (Sapropterin Dihydrochloride) Powder for Oral Solution 100 mg

Lot Numbers: T2202812, T2204053, T2300975, T2300976, T2304356

Expiration Dates: July 2025 to August 2026

NDC Number: 43598-097-30

The product, distributed nationwide to wholesalers/retailers, is intended to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).

Consumer Action: Consumers with the recalled product should contact their physician before discontinuing use and return it to the place of purchase.

For further inquiries, consumers can contact Dr. Reddy’s Laboratories Inc. at 866-733-3952 during office hours from 9 a.m. to 5 p.m. (EST) Monday through Friday. Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program.

Regulatory Compliance: This recall is conducted with the knowledge of the U.S. Food and Drug Administration (FDA), ensuring adherence to regulatory standards and consumer safety protocols.

About Dr. Reddy’s Laboratories Ltd.: Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company committed to providing access to affordable and innovative medicines. Established in 1984, the company focuses on various therapeutic areas and markets including the USA, India, Russia & CIS countries, China, Brazil, and Europe.

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