TOPIC: Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL by Dr. Reddy's: Recall - Due to Mislabeling of Infusion Bag
AUDIENCE: Patient, Health Care Professional, Pharmacy
ISSUE: Dr. Reddy’s Laboratories is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags in the United States.
The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Risk Statement: Patients who are administered the mislabeled product will likely experience adverse events. Because the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose, the patient could receive double the dose of intravenous levetiracetam than intended which could lead to immediate and serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma. Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events.
Dr. Reddy’s has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL (5mg/mL) are both indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible:
RECOMMENDATIONS:
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Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers with questions regarding this recall can contact Dr. Reddy’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG).
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Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement of all recalled products.
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Wholesalers, distributors, and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.
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For instructions on returning product or additional assistance, call Inmar at 1-877-645-1584.
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