NDC 16590-224
Tobramycin 3 mg per 1 mL solution/ drops
On the label: Stat Rx USA. It's repackaged: Stat Rx USA rebottles it from Akorn's NDC 17478-290.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it, tests it and sterilizes it | Not inspected on record |
| Akorn | Location not on file | Packages it and labels it | Not inspected on record |
Repackaging site
- Stat Rx USA, Location not on file · repackages it and relabels it
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Lots: Lot: 1C56A, EXP 2/28/2023; 1J50A, EXP 8/31/2023; 1K61A, EXP 9/30/2023 ; 1M27A, EXP 11/30/2023; - Jun 18, 2012 · Class III · Stat Rx USA
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Lots: Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tobramycin: every company that makes it
- Form
- solution/ drops
- Strength
- 3 mg per 1 mL
- Approval
- ANDA ANDA064096
- On the market since
- Jan 31, 1996
- Package NDCs
16590-224-05- Official label
- DailyMed (National Library of Medicine), updated Sep 4, 2012
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?