Drug Enforcement D-0117-2025

Failed Impurities/Degradation Specifications

Status

Ongoing

Classification

Class III

Report Date

December 18, 2024

Termination Date

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Product Information

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.
Product quantity
7,233 bottles
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0117-2025
Event ID
95811
Recall initiation date
November 22, 2024
Center classification date
December 12, 2024
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.
More code info
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