Penicillin-class Antibacterial, beta Lactamase Inhibitor
Where is Ampicillin and Sulbactam made?
12 companies sell it under their own name and 1 repackager rebottle it. Their labels name 7 factories in India, Italy and Romania.
India 4Italy 2Romania 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| AuroMedics Pharma LLC1 g / 0.5 g, 1 g / 2 g, 50 mg per 1 mL / 100 mg per 1 mL · NDC 55150-116, 55150-178, 55150-117 +2 | Apitoria Pharma Private LimitedMakes the active ingredient and tests it | Sangareddy, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Serious problems, FDA actionSep 2025 | |
| Eugia Sez Private LimitedMakes it, tests it and packages it | Mahabubnagar, India | Problems found, fixed voluntarilyMar 2019 | |
| Armas Pharmaceuticals Inc.1 g / 0.5 g, 1 g / 2 g, 5 g per 15 g / 10 g per 15 g · NDC 72485-416, 72485-417, 72485-418 | Onesource Specialty Pharma LimitedMakes it, tests it, packages it, labels it and sterilizes it | Bengaluru, India | Problems found, fixed voluntarilyFeb 2019 |
| Civica, Inc.1 g / 2 g · NDC 72572-136 | Onesource Specialty Pharma LimitedMakes it, tests it, packages it and sterilizes it | Bengaluru, India | Problems found, fixed voluntarilyFeb 2019 |
| Claris Lifesciences, Inc.1 g / 0.5 g, 1 g / 2 g · NDC 36000-094, 36000-095 | Antibiotice SAMakes it | Iasi, Romania | Problems found, fixed voluntarilySep 2025 |
| Hikma Pharmaceuticals USA Inc.1 g per 1.5 g / 0.5 g per 1.5 g, 1 g per 3 g / 2 g per 3 g, 50 mg per 1 mL / 100 mg per 1 mL · NDC 0641-6116, 0641-6117, 0641-6118 | Mitim S.r.l.Makes it, tests it, packages it and labels it | Brescia, Italy | Problems found, fixed voluntarilyMay 2023 |
| Northstar Rx LLC.1 g / 0.5 g, 1 g / 2 g, 5 g / 10 g · NDC 72603-220, 72603-335, 72603-444 | Istituto Biochimico Italiano Giovanni LorenziniMakes it | Aprilia, Italy | Problems found, fixed voluntarilyNov 2024 |
| Onesource Specialty Pharma Limited1 g / 0.5 g, 1 g / 2 g, 5 g per 15 g / 10 g per 15 g · NDC 83270-304, 83270-305, 83270-308 | Onesource Specialty Pharma LimitedMakes it, tests it, packages it and sterilizes it | Bengaluru, India | Problems found, fixed voluntarilyFeb 2019 |
| Avenacy Inc.1 g / 0.5 g, 1 g / 2 g, 5 g / 10 g · NDC 83634-109, 83634-110, 83634-108 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.1 g / 0.5 g, 1 g / 2 g, 5 g / 10 g · NDC 71288-031, 71288-032, 71288-033 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Roerig Unasyn1 g / 0.5 g, 1 g / 2 g, 50 mg per 1 mL / 100 mg per 1 mL · NDC 0049-0013, 0049-0710, 0049-0014 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals1 g / 0.5 g, 1 g / 2 g, 50 mg per 1 mL / 100 mg per 1 mL · NDC 25021-142, 25021-143, 25021-144 | The label doesn't name the factory. Plants this company names for other drugs | ||
| WG Critical Care, LLC.1 g / 0.5 g, 1 g / 2 g, 5 g / 10 g · NDC 44567-210, 44567-150, 44567-211 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ampicillin and Sulbactam in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Medical Purchasing Solutions, LLC.:
71872-7367
Recalls
- May 29, 2020 · Class II · Pfizer Inc.
Presence of Particulate Matter: particulate matter identified after reconstitution. - 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. - 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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.