Drug recall D-0117-2025

Class III Ongoing reported Dec 18, 2024

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.

Reason for recall

Failed Impurities/Degradation Specifications

Lots and codes

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.

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
7,233 bottles
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 22, 2024

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