The FDA found uncontrolled manufacturing practices.
The Phillips Company of Sun City, AZ, is recalling all of its topical antibiotic products, according to an announcement from the FDA. The recall is voluntary and affects all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain, and LidoMed.
An inspection by the FDA of the company’s manufacturing facilities found significant manufacturing practices that were not in adequate control and which could affect the “safety, identity, strength, quality and purity of unexpired drug products made at the firm during the past three years.” These practices could “represent the possibility of risk being introduced into the manufacturing process in decreased quality and consistency of the product. These may have an impact on the safety and efficacy of the product posing a risk to patients,” according to the FDA. However, no adverse reactions have been reported.
All of the products affected by the recall are distributed in 5 mL dropper bottles and are intended to be used topically. They are marketed for the treatment of minor cuts and scrapes, as skin cleansers, or to promote hair growth. The products were distributed nationally.
Phillips Company is notifying its distributors and customers via recall letters. Anyone who has a product that is being recalled is instructed to stop using it immediately and return any unused product to the manufacturer.
Any adverse reactions or quality problems experienced with these products can be reported to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm online or by mail or fax.