Potentially deadly bacteria leads to recalls of a skin care cream and a breast compress
Two drug products — Regenecare HA Hyrdogel, a cream used for skin irritations, and Happy Ducts Compress, used by nursing women — have been recalled for possible contaminants that could lead to life-threatening complications.
The United States Food and Drug Administration listed the recalls this week.
Regenecare HA Hydrogel recall
On Wednesday, Mesquite, TX MPM Medical recalled one lot of Regenecare HA Hydrogel after receiving two customer complaints of visible contamination.
The product — used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations — was found to be contaminated with the bacteria Burkholderia cepecia.
The bacteria could cause local skin infections but 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, according to the FDA.
MPM Medical had not received any reports of adverse events when it issued its recall.
Regenecare HA Hydrogel is an over the counter product sold nationwide at pharmacies. The cream contains 2% lidocaine and is packaged in 3 ounce plastic tubes and distributed in boxes of 12.
How to spot the gel product
The recalled Regenecare can be identified by NDC #66977-107-03, and the lot number 41262 with date 2021-01 stamped on the tube crimp.
The company suggests that patients and healthcare facilities that have the recalled Regenecare should stop using it and can return the product.
Consumers with questions can call MPM Medical at 800-232-5512 from 7 a.m. to 5 p.m. Central Monday through Friday.
Also, tell your doctor if you have any problems after using the recalled gel.
“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,” the company said in a statement.
Happy Ducts Compress recall
On Tuesday, WishGarden Herbs Inc. recalled one lot of Happy Ducts Compress after it learned of a possible supply chain contamination.
The reported Happy Ducts product — used by nursing women as an external compress applied to breast tissue — contained the Cronobacter sakazakii bacteria.
Happy Ducts Compress, when contaminated with Cronobacter sakazakii and applied to breast tissue of nursing women, could result in serious and sometimes life-threatening infections of nursing infants, according to the FDA report.
“Infants can be exposed while nursing through residual bacteria on their mother’s skin. Additionally, topical application of Happy Ducts Compress contaminated with Cronobacter sakazakii may cause soft tissue infections in nursing women when applied to broken skin such as cracked nipples,” the report said.
How to spot the compress
The Happy Ducts Compress products recalled are in lot 53664 with an expiration date of August 2022 stamped above the barcode. They were sold through select practitioners and online retailers.
WishGarden Herbs had heard of no medical illnesses or harmful effects from the use of the compress when it made its recall. Most of the 46 units in distribution have been accounted for.
Catherine Hunziker, WishGarden president, said in a statement: “As a leading herbal product company for more than 40 years, we take the safety of our products seriously and we feel it is important to recall this product out of an abundance of caution. Consumer safety is our highest priority.”
Happy Ducts Compress is packaged in 3 ounce containers with UPC 6-56490-20223-5 on the label.
If you have the recalled compress WishGarden Herbs suggests you don’t open the package or stop using it immediately. You can mail it directly to WishGarden Herbs corporate headquarters at 321 S. Taylor Ave. Suite 100 Louisville, CO 80027 for a refund.
Call the company’s recall hotline at 720-889-9878 from 9 a.m. to 5 p.m. Mountain standard time or email: recall@wishgardenherbs.com.
To report adverse reactions to the FDA
If you’ve had an adverse reaction or other quality problems from using recalled products you can report what you experienced to the FDA’s MedWatch Adverse Event Reporting program either online by downloading the form, mail or fax. Call 800-332-1088 to request a reporting form.
