FDAFDA · Food and drugs·Recall number D-0485-2024
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Published May 15, 2024 · Recall initiated: April 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sub-potent Drug; powder discoloration associated with decreased potency
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- JAVYGTOR
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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