Regenecare HA Hydrogel Burkholderia Cepacia Sepsis Death Lawsuit Lawyers
Regenecare HA Hydrogel Recalled Due to Burkholderia Cepacia (B. Cepacia) Bacterial Contamination That Can Lead to Life-threatening Sepsis
According to pharmtech.com, the U.S. Food and Drug Administration (FDA) announced the recall of Regenecare HA Hydrogel due to possible Burkholderia cepacia (B. cepacia) contamination. MPM Medical, based out of Mesquite, Texas, announced on December 2, 2020, that the company had initiated a voluntary recall of one lot of its Regenecare HA Hydrogel product due to customer complaints of noticeable contamination. In a press release, MPM Medical affirmed that the product was contaminated with the bacteria Burkholderia cepacia (B. cepacia).
Regenecare HA Hydrogel is a topical gel that is used to relieve itching, pain, and discomfort associated with sunburn, minor burns, scrapes, minor cuts, insect bites, and other minor skin irritations. According to the company’s recall notice, the warning states that the use of a product contaminated with Burkholderia cepacia (B. cepacia) might lead to skin infections, which might allow the bacteria to spread into the user’s bloodstream, “leading to life-threatening sepsis.”
Regenecare HA Hydrogel is packaged in a 3 oz. plastic tube, and the product was distributed nationwide to healthcare facilities and wholesalers in boxes of 12 tubes. MPM Medical asserted that the company had not received any reports of complications or adverse events since the issuing of the recall announcement.
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