NDC 10544-883
Tobramycin 3 mg per 1 mL solution/ drops
On the label: Blenheim Pharmacal, Inc.. It's repackaged: Blenheim Pharmacal, Inc. 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
- Blenheim Pharmacal, Inc., North Blenheim, New York, United States · repackages 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;
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
- May 15, 2015
- Package NDCs
10544-883-99- Official label
- DailyMed (National Library of Medicine), updated May 15, 2015
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