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.
Suprax (cefixime for oral suspension)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Discoloration; Product may not meet specifications for color description once reconstituted.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
Affected NDC
68180-0202-03
Compare with the code on your package — it is the most precise check available.
Drug: Cefixime
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-202-03
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-264-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 2013 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
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