A company is recalling one lot of a prescription topical solution after testing showed it to be “super potent” and potentially fatally toxic, according to the FDA.
Teligent Pharma is recalling the lot of Lidocaine HCl Topical Solution 4% which comes in 50ml screw cap glass bottles, after testing found it to be “super potent,” the FDA said, and use of the super potent solution would result in a higher than intended dose.
An increased dose could lead to local anesthetic systemic toxicity, which can result in cardiovascular collapse, severe morbidity and death, the FDA said. Children of lower body weight and the elderly are more likely to be affected.
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