Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr.reddy's Laboratories Limited | Visakhapatnam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 17, 2024 · 9 inspections, 2 with FDA action |
Recalls
- May 1, 2024 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Lots: Lot H2200493; Exp 6/30/2025 - Jun 3, 2016 · Class III · Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Lots: Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sirolimus: every company that makes it
- Form
- tablet, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA201578
- On the market since
- Oct 27, 2014
- Package NDCs
55111-653-0155111-653-30- Official label
- DailyMed (National Library of Medicine), updated Sep 30, 2023
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