NDC 17478-151
Rifampin 600 mg per 10 mL injection, powder, lyophilized, for solution
On the label: Akorn.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Patheon Italia S.p.A | Ferentino, Italy | Makes it, tests it and packages it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Aug 20, 2015 · Class III · Akorn, Inc.
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Lots: Lot #: 14RIF1(A), Expiry: 9/30/2016. - Aug 5, 2014 · Class III · Akorn, Inc.
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Lots: Lot: 12RIF4A, Expiration Date: 9/30/2014
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rifampin: every company that makes it
- Form
- injection, powder, lyophilized, for solution
- Strength
- 600 mg per 10 mL
- Approval
- ANDA ANDA065502
- On the market since
- Jun 1, 2012
- Package NDCs
17478-151-42- Official label
- DailyMed (National Library of Medicine), updated Sep 13, 2022
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