NDC 55150-117
Ampicillin and Sulbactam 1 g / 2 g injection, powder, for solution
On the label: AuroMedics Pharma LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apitoria Pharma Private Limited | Sangareddy, India | Makes the active ingredient and tests it | Problems found, fixed voluntarilyDec 12, 2025 · 9 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Serious problems, FDA actionSep 5, 2025 · 8 inspections, 1 with FDA action |
| Eugia Sez Private Limited | Mahabubnagar, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMar 1, 2019 · 2 inspections |
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, intramuscular; intravenous
- Strength
- 1 g / 2 g
- Approval
- ANDA ANDA090349
- On the market since
- Feb 10, 2012
- Package NDCs
55150-117-10- Official label
- DailyMed (National Library of Medicine), updated Nov 4, 2025
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