Multi event Drug Recall Enforcement Report Class I voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 04-08-2024 for 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. The product was recalled due to sub-potent drug; powder discoloration associated with decreased potency. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0486-2024 | 04-08-2024 | 05-15-2024 | Class I | 2402 cartons | 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. | Sub-potent Drug; powder discoloration associated with decreased potency | Ongoing |
| D-0485-2024 | 04-08-2024 | 05-15-2024 | Class I | 17,332 cartons | 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 43598-097-30. | Sub-potent Drug; powder discoloration associated with decreased potency | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 43598-097 | Javygtor | Sapropterin Dihydrochloride | Powder, For Solution | Oral | Dr. Reddys Laboratories Inc | Human Prescription Drug |
