Topical products manufactured by Phillips Company are being recalled due to concerns of the manufacturing process the FDA officials said. This recall affects products made by the company in the past three years due to an FDA inspection that found significant manufacturing practices that question the safety, identity, strength, quality, and purity of the drug products.
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. These products are used for the treatment of minor cuts, scrapes, and burns; or as skin cleansers or hair growth promoters. All of the products included in the recall were distributed in 5 mL dropper bottles for topical application. The expiration date is printed on the label on the bottle. Products were distributed nationwide as wholesale products.
These products may pose a risk to patients due to the inadequate control causing a possible risk during the manufacturing process due to the possible decreased quality and consistency of the product. This may reduce the effectiveness of the product, inadvertently posing a risk to patients. No adverse events have been reported to date.
Phillips Company is notifying its distributors and customers by the 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. Consumers with questions regarding this recall can contact Phillips Company by e-mail (firstname.lastname@example.org).
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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- RECALL: file