Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Srikakulam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 20, 2022 · 5 inspections |
Recalls
- Apr 8, 2024 · Class I · Dr. Reddy's Laboratories, Inc.
Sub-potent Drug; powder discoloration associated with decreased potency
Lots: Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sapropterin: every company that makes it
- Form
- powder, for solution, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA209452
- On the market since
- Sep 16, 2022
- Package NDCs
43598-097-1143598-097-30- Official label
- DailyMed (National Library of Medicine), updated Oct 21, 2024
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