Federal health officials have announced a recall of certain over-the-counter topical pain and itch relief creams, due to a risk the products may be contaminated with Burkholderia cepecia, which may cause potentially serious infections.
The MPM Regenecare Hydrogel recall was announced by the U.S. Food and Drug Administration (FDA) on December 2, after the manufacturer received at least two customer complaints of visible contamination. However, to date, no injuries have been reported in relation to the recall.
The recalled pain and itch relief creams are used topically for relief of skin irritation caused by minor burns, sunburn, cuts, scrapes, insect bites or other injuries.
According to the notice, MPM Regencare Hydrogel cream may be contaminated with Burkholderia cepecia, which could cause consumers to develop mild to severe skin infections.
Officials are warning that immunocompromised individuals, such as patients receiving chemotherapy or those with cystic fibrosis, could experience potentially life threatening sepsis due to the potential for the infection to spread into the blood stream. Symptoms of these infections could result in fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion and even death if not treated immediately.
The recall includes Regenecare HA Topical Anesthetic Hydrogel containing 2% lidocaine marked with NDC # 66977-107-03, and the lot number 41262 with date 2021-01 debossed on the tube crimp. The products were manufactured by MPM Medical, LLC and were packaged in 3 oz. plastic tubes and distributed in boxes of 12 to wholesalers and healthcare facilities nationwide.
The manufacturer is instructing customers to stop using the recalled lot of Regenecare Hydrogel immediately and quarantine the product to prevent further use.
Burkholderia cepecia involves a group of complex bacteria that can be found in soil and water, and is often resistant to many common antibiotics, posing an increased risk to those with weakened immune systems such as children and the elderly.
Although the bacterial infection poses no significant threat to healthy individuals, those with respiratory infections, specifically cystic fibrosis and chronic lung disease may be more susceptible to the bacteria and require immediate medical treatment.
MPM announced they will begin notifying customers and distributors of the recall and will provide instructions on how to return all recalled products. For additional questions or concerns regarding the recall, customers may contact MPM Medical at 800-232-5512.
Customers who have experienced any adverse reactions or quality products related to the product are encouraged to report the incident to the FDA’s MedWatch Adverse Event Reporting program.