Lupin Pharmaceuticals Inc. is recalling 4,554 bottles of Cefixime for Oral Suspension USP, 100 mg/5 mL (50 mL bottle). Testing during an 18-month stability study revealed that the medication was subpotent, meaning it did not contain the full required strength of the active ingredient. This antibiotic is used to treat bacterial infections, and a lack of potency could reduce its effectiveness.
A subpotent drug delivers a lower dose than intended, which can lead to treatment failure or the worsening of a bacterial infection. This specific defect was discovered during long-term stability testing.
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Manufactured for Lupin Pharmaceuticals, Inc. (Baltimore, MD) by Lupin Limited (Mandideep, India).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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