JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
Wed Dec 18 2024
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Summary
Failed Impurities/Degradation Specifications: The observed impurity level was 0.15%, exceeding the specification limit of not more than 0.12%.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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. | Dr. Reddys Laboratories Inc | U.S. Nationwide | 7,233 bottles |