Javygtor Powder, For Solution
FDA Recall NDC 43598-097
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 43598-097). A significant event, classified as Class I, was initiated on Apr 08, 2024 by Dr. Reddys Laboratories Inc. The reported reason for this action was: "Sub-potent Drug; powder discoloration associated with decreased potency"
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
April 2024 Class I Recall: Sub-potent Drug; powder discoloration associated with decreased potency
Recall Number
Class I Ongoing
Sub-potent Drug; powder discoloration associated with decreased potency
Apr 08, 2024
May 15, 2024
17,332 cartons
Recall Profile & Regulatory Data
Event ID
94369
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# : T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
Affected Packages Involved in this Recall
43598-097-11Product
43598-097-30Product
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.
