Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distri
Recalled May 15, 2024 · FDA recall D-0485-2024 · Dr. Reddy's Laboratories
Hazard
Sub-potent Drug; powder discoloration associated with decreased potency · FDA Class I
Units
17,332 cartons
Sold at
Nationwide in the USA
Description
Sub-potent Drug; powder discoloration associated with decreased potency
Product
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.
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →