The regulatory agency previously had warned against using PharmaTech's oral liquid docusate, after the Centers for Disease Control and Prevention detected a strain of the bacteria in the product following a 2016 multistate outbreak of infections.
The recall, which distributors issued as a precautionary measure, follows a separate recall Rugby initiated last week after the FDA received two reports of Burkholderia cepacia infections in patients that may be linked to liquid stool softeners manufactured by PharmaTech.
PharmaTech's liquid products, including drugs and dietary supplements used in infants and children, are distributed nationwide. Consumers can contact their physician or healthcare provider if they have additional questions about this product.
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"Patients who are using liquid drug products and who have concerns should contact their health care professional", the FDA advises.
The FDA reported several reports of B. cepacia infections in patients involving PharmaTech's Diocto Syrup and Diocto Liquid. "You can watch for [Form 483s] or warning letters and try to avoid those companies, but at the end of the day if you don't know the company that actually made the product, you can't really know what you are buying", she added. Rugby then issued a voluntary recall of the PharmaTech-manufactured docusate sodium solutions.