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The product is being recalled because of Burkholderia cepecia contamination.
MPM Medical (Mesquite, TX) announced on Dec. 2, 2020 that it is voluntarily recalling one lot of Regenecare HA Hydrogel because of two customer complaints of visible contamination. The company stated in a press release that the product was contaminated with the bacteria, Burkholderia cepecia (B. cepacia).
Regenecare HA Hydrogel is a topical product is used for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations. According to the company, use of product contaminated with B. cepacia could cause skin infections, which could spread into the blood stream in patients that are immunocompromised, leading to life-threatening sepsis.
The product is packaged in 3 oz. plastic tubes and was distributed nationwide to wholesalers and healthcare facilities in boxes of 12. The company has not received any reports of adverse events as of the date of the recall announcement. Adverse events may be reported to FDA through its MedWatch program.