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
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
Affected NDC
27437-0207-02
Compare with the code on your package — it is the most precise check available.
Drug: Cefixime
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 27437-207-02
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1186-2014 · 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 2014 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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