MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination

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.

Consumers with questions regarding this recall can contact MPM Medical by phone at 1-800-232-5512 (toll-free) Monday through Friday between 7AM and 5PM CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

MPM Medical is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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