Class III
Ongoing
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.
This recall is currently active, issued December 18, 2024. It was issued by Dr. Reddy'S Laboratories, Inc..
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- November 22, 2024
- Posted
- December 18, 2024
- Recall Number
- D-0117-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7,233 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
U.S. Nationwide
Lot / Code Info
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.
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