Thu, 10/14/2021 - 08:45
Teligent Pharma, Inc. is voluntarily recalling specific lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the patient level. The product is being recalled because the testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.
The following Lot Numbers may have been dispensed by Express Scripts Pharmacy:
Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose 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. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall.
• You can find general information about this recall on the FDA website:
• Express Scripts will mail letters to any patient who was dispensed Lidocaine Topical Solution 4% 50mL within the last 6 months.
• Patients who have received Lidocaine Topical Solution 4% 50mL should check the lot number on the package to determine whether they are impacted.
• Patients that have impacted lot numbers for the Lidocaine HCl Topical Solution 4% are asked to discontinue use and dispose of the product immediately.
• If you choose to stay on this therapy but need to obtain a fresh supply and it is not time for your next refill, please call us at the toll free number on your prescription bottle to request an early refill. Your order will be filled with medication that is not part of any existing recall.
• Please be aware that your home delivery pharmacy is not able to accept returns or credit your account for the recalled drug.
• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
You can also report adverse events or quality problems related to the use of the drug to the FDA’s MedWatch Adverse Events Reporting Program. Call 800.FDA.1088 or go to https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Last updated: Thu, 10/14/2021 - 09:35