Medicine Recalled Over Contamination Issues

It may be time to check your medicine cabinet, because another recall has been issued affecting a popular wound care product. Blaine Labs Company in late January issued a voluntary recall of one lot of RevitaDerm Wound Care due to potential bacterial contamination after it was determined the products may be contaminated with Bacillus cereus, which can cause life-threatening in some patients, according to a Jan. 27-date recall notice by the U.S. Food and Drug Administration.

The recall covers one lot of 1.0 ounce RevitaDerm Wound Care Gel. The product is packaged in a 1.0 ounce bottle and a 3.0 ounce tube, with both labeled as “RevitaDerm Wound Care Gel” with a Drug Facts label on the back. The recall only covers products with the lot number BL 2844 and an expiration date reading 02/19/2023. According to the recall notice, the affected products can be “identified by its name on the front of either the 1.0 ounce bottle or the 3.0 ounce tube, and the 1.0 ounce volume has the witch-hat dispensing cap.”

The recalled RevitaDerm Wound Care Gel was distributed to 61 physician clinics in 17 states in the United States in the year 2021. According to the FDA, after determining the product is contaminated with Bacillus cereus, Blaine Labs has been in the process of notifying its physician clients by email, regular mail and by phone. The company is arranging for the return of undispensed 1.0 ounce bottles and 3.0 ounce tubes from lot BL 2844. Meanwhile, patients are being encouraged to immediately stop use of the product. They can return unused product to the dispensing physician.

According to the FDA’s recall notice, patients who use the contaminated product could develop a skin and soft tissue infection which could lead to serious complications. While the infections are typically less severe and responsive to treatment for non-immunocompromised patients, “for the immunocompromised patients and preterm neonates, Bacillus cereus can cause life-threatening, invasive infections including wound and blood infections, sepsis, pneumonia, and meningitis.” At this time, there have been no reports of adverse events related to the recalled product.

The Blaine Labs Company recall marks just the latest medicinal recall. In early February, the FDA posted a recall for at-home COVID-19 tests that were imported illegally and not approved by public health officials. The tests were manufactured by the South Korean diagnostics company SD Biosensor. Just prior to that, certain bottles of Geri-Care Brand over-the-counter acetaminophen and aspirin were recalled due to packaging that was not child-resistant.