Dr. Reddy’s Laboratories Ltd is voluntarily recalling 6 lots of Sapropterin Dihydrochloride Powder for Oral Solution 100mg due to powder discoloration in some packets leading to decreased potency. This issue was identified during an accelerated stability test and was also reported by customers.
Sapropterin Dihydrochloride Powder for Oral Solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients 1 month of age and older with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria.
The affected products were distributed nationwide to wholesalers and retailers, and include the following lots:
- Javygtor™ (sapropterin dihydrochloride) Powder for Oral Solution 100mg; NDC Number 43598-097-30
- Lot # T2202812; Expiration date 7/2025
- Lot # T2204053; Expiration date 10/2025
- Lot # T2300975; Expiration date 2/2026
- Lot # T2300976; Expiration date 2/2026
- Lot # T2304356; Expiration date 8/2026
- Sapropterin Dihydrochloride Powder for Oral Solution 100mg; NDC Number 43598-477-30
- Lot # T2200352; Expiration date 12/2024
Continuous administration of a subpotent product could lead to chronically elevated Phe levels that may result in potentially serious adverse events. At this time, there have been no reports of injury related to this recall.
Adverse events related to this recall should be reported to FDA’s MedWatch Adverse Event Reporting program.
References:
US Food and Drug Administration. Dr. Reddy’s issues voluntary nationwide recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to sub-potency. News release. Dr. Reddy’s Laboratories Inc. April 23, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg.
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