NDC 68180-405
Cefixime 100 mg per 5 mL powder, for suspension
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Mandideep, India | Makes it, makes the active ingredient and packages it | Serious problems, FDA actionNov 23, 2022 · 6 inspections, 3 with FDA action |
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.
Lots: Lot #: F201517, Exp 11/30/2024 - May 30, 2024 · Class II · Lupin Pharmaceuticals Inc.
Failed Content Uniformity Specifications
Lots: Lot F201519, Expiry: November 2024 - Jan 3, 2024 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications
Lots: Lot #: F304833, Exp 06/2025 - Apr 29, 2021 · Class II · Lupin Pharmaceuticals Inc.
Subpotent Drug
Lots: Lot #: F900787, Exp. Date 4/2021 - Apr 15, 2020 · Class II · Lupin Pharmaceuticals Inc.
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Lots: Lot #: F800779, Expiry 4/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cefixime: every company that makes it
- Form
- powder, for suspension, oral
- Strength
- 100 mg per 5 mL
- Approval
- ANDA ANDA065129
- On the market since
- Apr 24, 2015
- Package NDCs
68180-405-01- Official label
- DailyMed (National Library of Medicine), updated Oct 14, 2025
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