An over-the-counter lidocaine gel used to provide temporary relief from pain and itching associated with minor skin irritations such as burns, cuts, sunburn, scrapes, and insect bites was recently recalled.
MPM Medical of Mesquite, Texas is voluntarily recalling one lot of Regenecare HA Hydrogel following two customer complaints of visible contamination.
The same issue of a product being contaminated with dangerous impurities was also the main concern for the heartburn medication, Zantac.
Only in the drug’s case, it was contaminated with dangerous amounts of NDMA, a cancer-causing agent.
Even though many contaminated batches have already been recalled by a number of American health agencies, people who took Zantac over the course of several years still suffered from several types of cancer because of the substance.
An increasing number of people who have been injured and have suffered from medical problems because of the medication are now filing Zantac lawsuits in order to seek justice and rightful compensation.
Although not contaminated with carcinogens, the cream that was subjected for recall discussed in this article also pose life-threatening risks to patients.
Why It Could Be Harmful For Patients
The product was found to be contaminated with the bacteria Burkholderia cepecia.
According to the FDA, topical application of the contaminated gel may result in local skin infections.
“For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which includes symptoms such as fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion, and possibly death,” the announcement stated.
MPM Medical had not received any reports of adverse events when it issued the product’s recall.
How You Can Identify The Affected Product
Regenecare HA Hydrogel is an over-the-counter product sold nationwide at pharmacies.
The cream contains 2% lidocaine and is packaged in 3-oz. plastic tubes and distributed in boxes of 12.
The recalled Regenecare product can be identified by NDC # 66977-107-03, and the lot number 41262 with date 2021-01 stamped on the tube crimp.
“MPM is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue,” the company said in a statement.
What You Can Do
MPM Medical is notifying its distributors and customers of the recall and is arranging for the return of the affected product.
The company also suggests that patients and healthcare facilities in possession of the recalled product should stop using or dispensing it.
Consumers with questions related to this recall can call MPM Medical at 800-232-5512 from 7 A.M. to 5 P.M. Monday through Friday, CST.
You should also tell your doctor if you have experienced problems after using the recalled gel.
You can also direct concerns about adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.