NDC 61919-918
Gentamicin Sulfate 3 mg per 1 mL solution/ drops
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Akorn's NDC 17478-283.
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
- Feb 22, 2019 · Class II · Akorn, Inc.
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Lots: Lot 7B71A, Exp 01/2020 - Oct 8, 2018 · Class II · Akorn, Inc.
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Lots: Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Gentamicin: every company that makes it
- Form
- solution/ drops
- Strength
- 3 mg per 1 mL
- Approval
- ANDA ANDA064163
- On the market since
- Mar 19, 2019
- Package NDCs
61919-918-05- Official label
- DailyMed (National Library of Medicine), updated Jan 10, 2024
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