Buena, New Jersey-based Teligent Pharma, Inc. has voluntarily recalled two lots of Lidocaine HCl Topical Solution USP 4% after testing found it to be super potent.
Out-of-spec testing results are a common reason for drug recalls. However, for Teligent, this is not the first time that they faced the same problem. In fact, prior to this recall, the company has faced several manufacturing issues in recent years.
What is a lidocaine topical solution for?
Lidocaine HCl Topical Solution USP 4% is an anesthetic. It can cause loss of feeling in the skin and surrounding tissues, particularly in the oral and nasal cavities and proximal parts of the digestive tract.
The lidocaine comes in a 50 mL glass bottle. It was distributed to wholesalers and retailers nationwide.
Here are the product details:
- Lidocaine Hydrochloride Topical Solution USP 4%, 50mL bottle, NDC number 63739-997-64 with lot number 15594 and an expiration date of May 2023; and lot number 16345 with an expiration date of January 2024.
Reason For The Recall
The product recall was initiated after company testing has found it to be super potent at the nine-month and 18-month stability timepoints.
According to the FDA, use of the super potent product could result in patients getting a higher lidocaine dose than intended. Too much lidocaine could result in local anesthetic systemic toxicity.
According to the company, this depends on the duration of treatment and the specific patient. This toxicity can lead to central nervous system reactions such as excitation and depression, or more serious signs of cardiovascular toxicity, including low blood pressure, slower heart rate, and even cardiovascular collapse.
Moreover, local anesthetic systemic toxicity isn’t recognized and promptly treated, severe morbidity and even death can result, Teligent warned.
Adults and the elderly population who are more likely to use this product and children of lower body weight also have an increased risk of developing local anesthetic systemic toxicity if a higher than intended lidocaine dose is administered.
To date, Teligent has not received any safety reports related to its recall.
Not The First Time For The Company
Teligent didn’t say where the affected lidocaine lots were manufactured. Back in September, the company also recalled one lot of its lidocaine topical solution over superpotency concerns.
Two years ago, the FDA also raised manufacturing concerns against the company. The regulating agency reprimanded the generics company for making its skin medication available to the public even though it failed multiple stability tests.
In a November 2019 warning letter, the FDA said that Teligent’s Buena, New Jersey, manufacturing site didn’t properly investigate the test results for its clobetasol propionate lotion, a medication used to treat a variety of skin conditions, including eczema, psoriasis, and dermatitis, among others.
