Product: 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.
Reason for recall: Failed Impurities/Degradation Specifications
Recall initiated: 20241122
Status: Ongoing
Classification: Class III
Recall type: Voluntary: Firm initiated