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 43598-477-30.
FDA recall notice · announced May 15, 2024 · Dr. Reddy's Laboratories
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
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 43598-477-30.
Reason for recall
Sub-potent Drug; powder discoloration associated with decreased potency
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot # T2200352, Exp. 12/31/2024
Quantity: 2402 cartons
Status: Ongoing
Products in this recall event:
- 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 435 (D-0485-2024)
- 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 43598-477-30. (D-0486-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.