NDC 55150-178
Ampicillin and Sulbactam 1 g / 0.5 g injection, powder, for solution
On the label: AuroMedics Pharma LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Serious problems, FDA actionSep 5, 2025 · 8 inspections, 1 with FDA action |
Recalls
- May 1, 2018 · Class I · AuroMedics Pharma LLC
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Lots: Lot #: AS0317041-A, AS0317035-A; Exp August 2019 - Jan 2, 2018 · Class I · Aurobindo Pharma Ltd.
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Lots: Lot Number AF0117001-A
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ampicillin and Sulbactam: every company that makes it
- Form
- injection, powder, for solution, intravenous
- Strength
- 1 g / 0.5 g
- Approval
- ANDA ANDA090340
- On the market since
- Sep 13, 2012
- Package NDCs
55150-178-99- Official label
- DailyMed (National Library of Medicine), updated Aug 12, 2025
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