Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Cefixime for Oral Suspension USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Affected NDC
68180-0405-01
Compare with the code on your package — it is the most precise check available.
Drug: Cefixime
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cefixime NDC 68180-0405 |
100 mg/5mL | Powder, for Suspension Oral |
Lupin Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-405-01
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1252-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cefixime recalls
See all
Class II · Moderate risk
Cefixime for Oral Suspension USP 200 mg/5 mL
Failed Content Uniformity Specifications
Class II · Moderate risk
Cefixime for Oral Suspension 100mg/5mL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime 400 mg capsule
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Other recalls by Lupin Pharmaceuticals Inc.
All 2020 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
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Class II · Moderate risk
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prednisoLONE Acetate Ophthalmic Suspension
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Liraglutide Injection
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