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.
Recall Number: D-0117-2025
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class III
Status: Ongoing
Report Date: 20241218
Initiation Date: 20241122
Termination Date:
Reason for Recall
Failed Impurities/Degradation Specifications
Product Description
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.