Second recall of anesthetic for issue that can cause ‘severe morbidity, even death’
For the second time in just over six weeks, Teligent Pharma recalled Lidocaine HCl Topical Solution 4%, 50ml for super potency.
This time, instead of just one lot, Teligent pulled five lots, four distributed by Teligent and one by Sky Packaging.
Here’s what you need to know.
What is lidocaine and which varieties are recalled?
Lidocaine is a prescription medication used to prevent or relieve pain in the mouth, nose and part of the digestive tract. Under recall: Lidocaine HCl Topical Solution 4% in a 50ml screw cap bottle.
▪ The Teligent distributed lot Nos. are 13262, expiration 03/2022; 14217, expiration 08/2022; 13058, expiration 02/2022; and 13768, expiration 05/2022. They have NDC No. 52565-009-50.
▪ The Sky Packaging distributed lot is No. 16306, expiration 01/2024, with NDC No. 63739-997-64.
Why is ‘super potency’ bad?
Too much of any drug or medication has consequences. The risk statement in the Teligent-written, FDA-posted recall alert says lidocaine of too much strength can lead to “local anesthetic systemic toxicity.”
“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,” the statement says. “If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.”
What do you do now?
Teligent is notifying distributors. Customers should stop using the lidocaine and toss it. Then talk to your pharmacist or Teligent about a refund.
Consumers with questions about the recall can email Medical@teligent.com or call Teligent at 856-697-1441, then press the * key, Monday through Friday, 8 a.m. to 5 p.m., Eastern Time.
If this or any drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
This story was originally published October 13, 2021 at 11:22 AM with the headline "Second recall of anesthetic for issue that can cause ‘severe morbidity, even death’."
