Javygtor (sapropterin dihydrochloride) Powder for Oral Solut… recall — Class I (D-0485-2024) · pharmaranks
Class IOngoing
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg recall
FDA recall D-0485-2024 · initiated Apr 8, 2024
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Sub-potent Drug; powder discoloration associated with decreased potency
Details
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.
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.