What’s the Problem?
According to the U.S. Food & Drug Administration (FDA), this recall affects:
- 3 oz. Regenecare HA Hydrogel — NDC # 66977-107-03 — lot number 41262 — date 2021-01.
“Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections,” FDA said. “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 recall was issued following 2 customer complaints of visible contamination, which was subsequently found to be Burkholderia cepecia bacteria.
Consumers with questions regarding the recall can contact MPM Medical Monday through Friday between 7AM and 5PM CST.
If you have experienced any adverse reactions or quality problems experienced with the use of Regenecare, you should contact your healthcare provider immediately.
This recall began on December 2, 2020.
Do I Have a Regenecare Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Regenecare Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or another loved one was injured by the side effects of Regenecare, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.