SAPROPTERIN DIHYDROCHLORIDE Recall D-0485-2024
Description: 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.
SAPROPTERIN DIHYDROCHLORIDE Recall D-0485-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0485-2024 |
| Event ID | 94369 |
| Brand | JAVYGTOR |
| Generic Name | SAPROPTERIN DIHYDROCHLORIDE |
| Manufacturer | SAPROPTERIN DIHYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | SAPROPTERIN DIHYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 17,332 cartons |
| Recall Reason | Sub-potent Drug; powder discoloration associated with decreased potency |
| Drug Classification | Class I |
| Drug Code Info | 20240515 |
| Product NDC | 43598-097 |
| Recall Initiation Date | 20240408 |
| Report Date | 20240515 |
| Classification Date | 20240506 |
| Address | 107 College Rd EN/A Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | RG277LF5B3 |
| Drug Application Number | ANDA209452 |
| Structured Product Labeling (SPL ID) | ecb86af2-3917-0f6e-b88c-b869f7350c0a |
| Structured Product Labeling (SPL Set ID) | 1590afa1-baa4-70e5-5a3b-468401c71044 |
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