FDA-Drug2024-12-18Class III
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.
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Impurities/Degradation Specifications
Sold states
U.S. Nationwide
Affected count
7,233 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0117-2025Don't want to check this manually?
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