FDAHealthNovember 22, 2024

Dr. Reddy's Laboratories, Inc. — Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 435

⚠️ Failed Impurities/Degradation Specifications

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: November 22, 2024

U.S. Nationwide

What's affected?

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.
Brand: JAVYGTOR
UPC: 0343598096049
Lot code: T2300653

Additional details

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.

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 7,233 bottles.

View original FDA notice →

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