FDA Recalls Pharmacal OTC Cream Contaminated with Staph

The US Food and Drug Administration (FDA) and Pharmacal are recalling one lot of MG217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube to the consumer level. The product has been found to be contaminated with Staphylococcus aureus.

Pharmacal is notifying its distributors via an emailed letter and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using and discard the product.

To date, Pharmacal has not received any reports of adverse events related to this recall.

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.

The product is used as a topical cream and comes in a 6oz tube with product code 5106 and UPC 012277051067.

The affected MG217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream is lot 1024088 with expiration date of November 2026. The product can be identified by locating the lot number in the crimped end of the tube. MG217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream was distributed nationwide to wholesale, retail (H-E-B Grocery) and Amazon.

Makary Is Out

In other FDA, Commissioner Makary is no longer with the FDA, as speculated in Happi. President Donald Trump announced that Kyle Diamantas, the agency’s food regulator, would be the acting FDA commissioner.