FDA-Drug2024-05-15Class I
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Dr. Reddy's Laboratories, Inc.
Hazard
Sub-potent Drug; powder discoloration associated with decreased potency
Sold states
Nationwide in the USA
Affected count
17,332 cartons
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0485-2024Don't want to check this manually?
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