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Drug Safety Alerts
Lidocaine Voluntary Recall
8/27/2021
On August 27, 2021, Teligent issued a consumer-level recall of one lot of Lidocaine Topical Solution 4% 50 mL. This recall was issued because testing found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.
This recall affects lot numbers 14218 exp. September 2022. No other lots are affected by this recall.
This could be a health hazard or safety risk to patients who may be using product affected by this recall.
According to Teligent, use of the super potent product would result in a higher than intended lidocaine dose, which could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered.
According to Teligent Pharma, Inc., as of the date of recall, it has not received any reports of adverse events related to this recall.
Teligent recommends that consumers and patients should return their unused product to the pharmacy where it was purchased. Consumers and patients should contact their physician for further medical advice.
CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using Lidocaine Topical Solution 4% 50 mL to contact their prescriber.
For more information about the Lidocaine Topical Solution 4% 50 mL, call Teligent at 1-877-622-2330, Monday through Friday, 8:00 am to 7:00 pm (CT). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.