Drug product
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.
D-0485-2024
Product summary
- Event
- Event 94369
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 17,332 cartons
- Official record key
drug-enforcement:D-0485-2024
Official wording
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Code information: Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Sub-potent Drug; powder discoloration associated with decreased potency