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FDARecalled Dec 18, 2024 · #D-0117-2025

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.

Hazard

Class III — low health risk

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Description

Failed Impurities/Degradation Specifications Classification: Class III Distribution: U.S. Nationwide

Product details

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.
Type
Drugs
Manufacturer
Dr. Reddy's Laboratories, Inc.
Model numbers
T2300653
UPCs