TOPIC: Lidocaine HCl Topical Solution 4% by Teligent Pharma: Recall - Due to Super Potency
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: Teligent Pharma is recalling five lots of Lidocaine HCl Topical Solution 4%, 50mL because the firm's testing has found it to be super potent based on an Out of Specification result obtained at the 18-month stability timepoint.
Use of the super potent product would result in a higher than intended lidocaine dose. 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. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults, the elderly who are more likely to use this product and 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 has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Lidocaine HCl Topical Solution 4% is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.
RECOMMENDATIONS:
- Consumers and patients that have Lidocaine HCl Topical Solution 4% which is being recalled are asked to discontinue use and dispose of the product immediately.
- Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
|
