A type of cream used to treat eczema and other conditions is under recall after it was found to be contaminated with a type of staphylococcus bacteria, according to a notice published on the Food and Drug Administration’s (FDA) website on Tuesday.
Drug company Pharmacal issued a recall for its Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, sold under the MG217 brand, for having potentially the life-threatening bacteria, Staphylococcus aureus.
It comes as a topical cream in a six-ounce tube with the product code of 5106 and UPC 012277051067, according to that notice. It has a lot number of 1024088 and an expiration date of November 2026.
“Use of the product could result in a range of infections from localized to severe or life-threatening adverse events. Patients with weakened immune systems or compromised skin — such as those with wounds, burns, or skin disorders — are at increased risk for serious infections, including skin and skin structure infections, infective endocarditis (infection of the heart valves), bone and joint infections, bloodstream infections, and life-threatening conditions like sepsis and septic shock,” said the recall notice on the FDA website.
The company said that it has not received any reports of adverse events connected to the product.
Pharmacal will notify distributors of the product and will arrange for the return of the recalled items. It warned that consumers who have the product should not use it and should discard it.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product,” the notice warned.
It did not say whether the product was sold, but an Epoch Times review shows that it was sold on Amazon.com, eBay, and other online websites. It also did not say how many of the items are under recall and did not say in which states the items were sold.
On the product labeling, it is billed by the company as hypoallergenic and also safe for infants and children, adding that it can be used as a full-body skin protectant moisturizer. The cream also provides “fast, long-lasting relief from itching, irritation, dryness, roughness, redness and cracking,” the company’s marketing for the product says.
The Centers for Disease Control and Prevention says on its website that Staphylococcus aureus infections can “lead to serious or fatal outcomes,” although in many cases “does not cause any harm.”
An infection can occur when the bacteria goes into a person’s skin or other parts of the body, sometimes causing blisters, boils, or sores on the skin, according to the Cleveland Clinic. But it can infect the blood, heart, lung, and other organs.
Symptoms of a staph infection can vary but affected areas of the skin can be swollen, warm to the touch, red or darker than normal, filled with liquid or pus, painful, itchy, crusty, or peeling, the clinic says.
If the infection spreads to other areas of the body, people can experience fever, muscle aches, fast heart rate, nausea or vomiting, diarrhea, bone and joint pain, low blood pressure, weakness, a cough, and other symptoms, it says.
The FDA recommends that adverse reactions to the cream be reported on the agency’s MedWatch Adverse Event Reporting webpage. People can also contact Pharmacal via email at aimho@pharmacalway.com.