NDC 68084-915
Sirolimus 1 mg tablet
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-653.
Where the pills inside were 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 |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- May 1, 2024 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Lots: Lot H2200493; Exp 6/30/2025 - May 12, 2021 · Class III · American Health Packaging
Failed Impurities/Degradation Specifications
Lots: Lot #: 1000789, Exp. Date 10/31/2022 - 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
- Nov 5, 2015
- Package NDCs
68084-915-2568084-915-95- Official label
- DailyMed (National Library of Medicine), updated Aug 20, 2025
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