NDC 68084-451
Tacrolimus 5 mg capsule
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-527.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- Dec 15, 2023 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Lots: Lot# C2307275; Exp. January 2026 - Feb 8, 2023 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Lots: Lot # C2106445; Exp. 03/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tacrolimus: every company that makes it
- Form
- capsule, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA090509
- On the market since
- Aug 3, 2010
- Package NDCs
68084-451-0168084-451-11- Official label
- DailyMed (National Library of Medicine), updated Oct 16, 2024
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