Medicine recalls
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| The United States: MPM Medical LLC issues voluntary nationwide recall of Regenecare HA Hydrogel due to Burkholderia cepecia contamination |
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The US Food and Drug Administration (FDA) announces that MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel (lot number: 41262) to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.
Topical application of Regenecare HA Hydrogel contaminated with Burkholderia 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 over-the-counter 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mpm-medical-llc-issues-voluntary-nationwide-recall-regenecare-ha-hydrogel-due-burkholderia-cepecia
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Dec 3, 2020
Issued at HKT 16:00
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