Summary
- Company Announcement Date:
- December 02, 2020
- FDA Publish Date:
- December 02, 2020
- Product Type:
- Drugs
- Reason for Announcement:
-
Burkholderia cepecia contamination.
- Company Name:
- MPM Medical, LLC
- Brand Name:
-
MPM Medical
- Product Description:
-
Regenecare HA Topical Anesthetic Hydrogel
Company Announcement
Mesquite, TX MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.
Risk Statement: 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 # 66977-107-03, and the lot number 41262 with date 2021-01 debossed on the tube crimp as shown in the images below. Regenecare HA Hydrogel Lot 41262 was distributed nationwide to wholesalers and healthcare facilities.
MPM Medical is notifying its distributors and customers by first class mail, electronic mail, and phone call and is arranging for return of all recalled product. Patients and healthcare facilities in possession of this product which is being recalled should stop using and dispensing.
