FDA – According to a media release from Teligent Pharma, Inc., the drug manufacturer issued a recall of a single lot of its “Lidocaine HCl Topical Solution 4%, 50ml” in a glass bottle with a screw-on cap. The urgent recall was launched subsequent testing that discovered the batch was “overly potent, resulting in higher than intended lidocaine doses.” The affected product has the identification “NDC# 52565-009-50” and has a lot number of 14218, with an expiration date of 09/2022. The recalled lot of Lidocaine HCl Topical Solution 4%, 50mL was distributed to both wholesale distributors and local retail stores throughout the United States and in Canada.
According to the recall announcement, excessive lidocaine exposure may lead to local anesthetic systemic toxicity depending on the length of exposure and the patient. Local anesthetic systemic toxicity may lead to severe central nervous system reactions such as depression, excitation, and dangerous signs of cardiovascular toxicity such as hypotension, bradycardia, and even cardiovascular failure. If a patient is an overdose and they are not treated promptly, a patient could die.
There have not been any reports of adverse health events related to this recall at this time. Teligent Pharma is contacting distributors and planning for the return of all affected products. Those who have the recalled Lidocaine products should bring them back to the place of purchase. Information and answers to questions regarding the recall may be directed to Teligent Pharma, Inc. The company’s contact information may be found on teligent.com.
Patients are advised to contact their healthcare provider should they experienced any problems related to using the recalled product.
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