Medicine recalls
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| The United States: Phillips Company issues voluntary worldwide recall of all topical products due to concerns of manufacturing practices |
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The US Food and Drug Administration (FDA) announces that 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. 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 for topical application. The expiration date is printed on the label on the bottle.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm563166.htm
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Phillips Company.
Ends/Thursday, Jun 15, 2017
Issued at HKT 14:00
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