Javygtor Tablet
FDA Recall NDC 43598-096
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Javygtor (NDC 43598-096). A significant event, classified as Class III, was initiated on Nov 22, 2024 by Dr. Reddys Laboratories Inc. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
November 2024 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications
Nov 22, 2024
Dec 18, 2024
7,233 bottles
Recall Profile & Regulatory Data
Event ID
95811
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
43598-096-30Product
43598-096-04Product
43598-096-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
