Mavidon announced that it is recalling its LemonPrep, Pedia Prep, Wave Prep and Cardio Prep due to potential contamination.
The company is recalling all lots of the specified products manufactured at its Riviera Beach, Fla.–based facility due to potential contamination with Burkholderia cepacia, which is an aerobic gram-negative bacillus found in various aquatic environments and an organism of low virulence that is a common colonizer of fluids used in hospitals.
Mavidon said in a news release that it was notified on Dec. 19, 2019, that samples of 114 gm tubes of Lemon Prep collected during an FDA inspection on Oct. 15, 2019, were tested and found to be contaminated with Burkholderia cepacia. The company exercised caution by recalling all products manufactured at the facility.
The affected LemonPrep, Pedia Prep, Wave Prep and Cardio Prep included in the recall are skin prep products. The 4-oz tubes and single-use cups for the first three were recalled, while the company recalled the Cardio Prep single-use cups as well.
Mavidon urged users to immediately stop using the product and quarantine it before making the necessary recall steps provided by the company and the FDA.
Mavidon also amended its initial recall to remove Collodions, Collodion Remover, Medical Adhesive Remover and Acetone from the recall.