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.
Reported: December 18, 2024 Initiated: November 22, 2024 #D-0117-2025
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 7,233 bottles
- Distribution
- U.S. Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 7,233 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2024. Severity: Low. Recall number: D-0117-2025.
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