Dr. Reddy's Laboratories, Inc. is recalling 4,010 bags of Levetiracetam 0.75% in Sodium Chloride Injection (1,000 mg/100 mL), a medication used to treat seizures. The infusion bags inside the packaging are incorrectly labeled with the wrong dosage (500 mg/100 mL) and an incorrect sodium chloride concentration (0.82%), though the outer aluminum overwrap displays the correct information. If a healthcare provider relies on the incorrect label on the bag, they may inadvertently administer twice the intended dose of the medication.
A dosing error caused by the incorrect label could lead to levetiracetam toxicity, potentially causing central nervous system depression, respiratory distress, or other serious adverse health effects.
Internal infusion bag incorrectly labeled as 500 mg/100 mL in 0.82% Sodium Chloride Injection.
Image 1 – Labeling, Product Overwrap Description Levetiracetam in 0.75% Sodium Chloride Injection 1000mg/100ml
Image 2 – Labeling, Product Infusion Bag Primary Description, with Error, Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag.
Image 3 – Labeling, Product Overwrap Description, Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL
Image 4 - Labeling, Product Infusion Bag Primary Description with No Error, Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL single-dose bag.
Image 5 – Labeling, Carton Levetiracetam, 10-single dose bags
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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