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The National Agency for Food and Drug Administration and Control has been informed by the U.S. Food and Drug Administration that MPM Medical has recalled one lot of Regenecare HA Hydrogel due to Burkholderi cepecia contamination.
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.
Topical application of Regenecare HA Hydrogel contaminated with Burkholderi 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 in breathing, low blood pressure, fast heart rate, mental confusion and possibly death.
Product Details
The details of the recalled lot of Regenecare HA Hydrogel are as follows;
| Product Name: | Regenecare HA Hydrogel |
| Product Manufacturer: | MPM Medical, LLC |
| Active Ingredient: | Lidocaine HCL 2% |
| Brand Name: | MPM Medical |
| Expiry Date | 01/2021 |
Recommendations
NAFDAC implores all importers, wholesalers, and retailers to immediately stop the importation, distribution, and use of the recalled products.
NAFDAC encourages Patients already using the affected lot of Regenecare HA Hydrogel to discontinue using the medication and consult your healthcare provider for alternative treatment.
Patients and healthcare providers are advised to report adverse events and quality problems they experienced using these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
