Cephalosporin Antibacterial
Where is Cefixime made?
4 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 4 factories in India.
India 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ascend Laboratories, LLC400 mg · NDC 67877-584 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited100 mg per 5 mL, 200 mg per 5 mL, 400 mg · NDC 65862-751, 65862-752, 59651-647 | Aurobindo Pharma LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilySep 2023 |
| Lupin Pharmaceuticals, Inc.100 mg per 5 mL, 200 mg per 5 mL, 400 mg · NDC 68180-405, 68180-407, 68180-416 +1 | Lupin LimitedMakes it, makes the active ingredient and packages it | Mandideep, India | Serious problems, FDA actionNov 2022 |
| Rising Pharma Holdings, Inc.400 mg · NDC 64980-430 | FDC LimitedMakes it and tests it | Solan, India | No problems foundFeb 2016 |
Repackaged by
These companies buy Cefixime 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.
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-079 - Health Department, Oklahoma State:
83112-400 - Remedyrepack Inc.:
70518-2749,70518-3221,70518-4759
Recalls
- Aug 21, 2024 · Class II · Lupin Pharmaceuticals Inc.
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. - May 30, 2024 · Class II · Lupin Pharmaceuticals Inc.
Failed Content Uniformity Specifications - Jan 3, 2024 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications - Dec 29, 2021 · Class II · RemedyRepack Inc.
Failed Impurities/Degradation Specifications - Dec 21, 2021 · Class II · Ascend Laboratories, LLC
Failed impurities/degradation specifications - Nov 3, 2021 · Class II · Ascend Laboratories LLC
Failed Impurities/Degradation Specifications - Apr 29, 2021 · Class II · Lupin Pharmaceuticals Inc.
Subpotent Drug - Apr 15, 2020 · Class II · Lupin Pharmaceuticals Inc.
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.