Cefixime Oral Suspension Recalled for Failed Content Uniformity Specifications
Lupin Pharmaceuticals is recalling one lot of Cefixime oral suspension (200 mg/5 mL) due to failed content uniformity specifications. The recall affects 3,552 bottles distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a pharmaceutical with a manufacturing quality defect. The content uniformity failure poses a risk of improper drug dosing to consumers, but no illnesses or injuries have been reported, placing it in the High category for risk-of-harm products without realized harm.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL pack size) due to failed content uniformity specifications. The affected lot is F201519 with an expiration date of November 2024.
Content uniformity failure means the concentration of the active ingredient (cefixime) may not be consistent across all units in the affected lot. This could result in some bottles containing subtherapeutic amounts of the medication (reducing its effectiveness) or supratherapeutic amounts (potentially causing adverse effects).
The recall affects approximately 3,552 bottles that were distributed nationwide in the United States. Consumers should not use the product if they possess this lot number. Those with questions about whether their medication is affected should contact Lupin Pharmaceuticals or consult a healthcare provider.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- content-uniformity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot F201519
- Expiry: November 2024
UPCs (4)
- 0368180423089
- 0368180407034
- 0368180416081
- 0368180416111
Distribution
Distributed nationwide across the United States.
Related recalls
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- ModerateCefixime oral suspension antibiotic recalled nationwide for subpotency
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- HighLupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications
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- ModerateCefixime Capsules 400 mg Recalled for Failed Impurities and Degradation
FDA (Drugs) · 2022-01-12
- ModerateCefixime Capsules 400 mg Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-11-17
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