Dr Reddy’s Laboratories is recalling one batch of Levetiracetam in 0.75 p.c Sodium Chloride Injection single-dose infusion luggage to the patron degree, in the US.
“The product is being recalled as a result of the infusion bag is incorrectly labeled as Levetiracetam in 0.82 p.c Sodium Chloride Injection 500 mg/100 mL single-dose bag, whereas the aluminum overwrap packaging appropriately identifies the product as Levetiracetam in 0.75 per cent Sodium Chloride Injection 1,000 mg/100 mL,” the corporate stated in a launch on Friday.
“Sufferers who’re administered the mislabeled product will seemingly expertise hostile occasions. As a result of the infusion bag is labelled as 500 mg/100 mL however truly comprises 1,000 mg/100 mL dose, the affected person might obtain double the dose of intravenous levetiracetam than supposed which might result in rapid and severe uncomfortable side effects together with hypersensitivity reactions, liver damage, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed degree of consciousness, respiratory despair, and coma,” the corporate stated.
Sufferers receiving excessive doses of levetiracetam by speedy intravenous infusion for the therapy of standing epilepticus can be “most in danger for extreme hostile occasions.”
The Hyderabad-based Dr. Reddy’s had not acquired any experiences of hostile occasions associated to this recall, the corporate stated.
Levetiracetam Sodium Chloride Injections are indicated for adjunct remedy in adults with some varieties of seizures when oral administration is quickly not possible.
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