More pain reliever recalled for a problem that can cause ‘severe morbidity... even death’
For the third time in four months, Teligent Pharma is recalling Lidocaine HCl Topical Solution USP 4% 50 ml for “super potency.”’
What’s been recalled?
Lot No. 15594 with expiration date 05/2023 and lot No. 16345 with expiration date 01/2024.
What’s the danger?
If a drug is super potent, the prescribed dose can give you more of the drug than is necessary or safe. With lidocaine, as the Teligent-written, FDA-posted recall notice states, that can lead to “local anesthetic system toxicity.”
And that “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 recall notice says. “If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.”
What do I do now?
Stop using it. For questions or instructions on reimbursement, either call 856-697-1441 and press the asterisk/star key, Monday through Friday, 8 am. to 5 p.m., Eastern time, or email Medical@teligent.com.
If this or any other drug causes a medical 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 December 13, 2021 at 1:16 PM.
