Phillips Company issues voluntary worldwide recall of all topical products due to concerns of manufacturing practices.
Phillips Company is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed distributed by Phillips Company, with business offices located in Sun City, Arizona, to the retail level. The products are being recalled after an FDA inspection found significant manufacturing practices that calls into question the safety, identity, strength, quality and purity of unexpired drug products made at the firm during the past three years.
Manufacturing practices that are not in adequate control 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. To date, no adverse events have been reported.
The topical antibiotic products are intended for treatment of minor cuts, scrapes and burns; or as skin cleansers or hair-growth promoters. All products are distributed in 5 mL dropper bottles (photo) for topical application. The expiration date is printed on the label on the bottle. Products were distributed nationwide as wholesale products.
Phillips Company is notifying its distributors and customers by issuance of recall letters, and is arranging for return of all recalled products. Consumers/distributors/retailers that have a product which is being recalled should stop using the product and return any unused and unexpired products to the manufacturer.