Drug Safety Alerts

Regenecare® HA Hydrogel Consumer-Level Recall

12/02/2020

On December 2, 2020, the United States Food and Drug Administration (FDA) published a consumer-level recall of Regenecare® HA Hydrogel NDC #66977-0107-03 manufactured by MPM Medical. This recall was issued because of potential product contamination with the bacteria Burkholderia cepecia.

This recall affects lot number 41262 exp. 01/2021.

Topical application of Regenecare® HA Hydrogel contaminated with B. cepacia 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. To date, MPM Medical has not received any reports of adverse events related to this recall.

Regenecare® HA Hydrogel is an OTC product that contains 2% lidocaine and is used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations and is packaged in 3 oz. plastic tubes and distributed in boxes of 12. The product can be identified by NDC #66977-0107-03, and the lot number 41262 with date 2021-01 debossed on the tube crimp.

MPM Medical recommends that consumers should stop using the affected product. Patients should call their healthcare provider further guidance and/or a replacement product.

CVS Caremark Response: Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please call MPM Medical at 1-800-232-5512 Monday through Friday between 7:00 AM and 5:00 PM (CST). You may also call the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.