NDC 61919-989
Ak-Poly-Bac 500 [USP'U] per 1 g / 10000 [USP'U] per 1 g ointment
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Akorn's NDC 17478-238.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it, tests it, packages it, labels it and sterilizes it | Not inspected on record |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Lots: Lot # 0G87A, EXP 06/30/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bacitracin and Polymyxin B: every company that makes it
- Form
- ointment
- Strength
- 500 [USP'U] per 1 g / 10000 [USP'U] per 1 g
- Approval
- ANDA ANDA064028
- On the market since
- Jan 1, 2014
- Package NDCs
61919-989-35- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2020
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?