Drug product
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.
D-0117-2025
Product summary
- Event
- Event 95811
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 7,233 bottles
- Official record key
drug-enforcement:D-0117-2025
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: T2300653, Exp 01/31/2025; T2303956, T2303750, Exp 06/30/2025; T2304190, T2304987, Exp 08/31/2025; T2302026, Exp 03/31/2025; T2302526, Exp 05/31/2025.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications