The recall affects a variety of distributors.
The FDA is advising health-care professionals and patients not to use any liquid drugs manufactured by PharmaTech, a drug manufacturer based in Davie, FL. The agency is telling anyone who purchased these products to immediately quarantine the products and contact their local FDA pharmaceutical recall coordinator.
The recall affects multiple distributors. Rugby Laboratories announced a recall of two PharmaTech drugs, Diocto Liquid and Diocto Syrup, on August 2, due to possible Burkholderia cepacia contamination. The FDA has also received adverse event reports related to oral liquid docusate sodium problems, including recent patient infections. The FDA has said that it “might be difficult to determine the manufacturer because these liquid products are not labeled with a PharmaTech label,” and thus the agency is recommending that pharmacies check with their supplier to determine the manufacturer. Since the initial recall from Rugby, the FDA has also named Leader Brand and Major Pharmaceuticals as two other distributors.
A CDC investigation in 2016 revealed the same bacterium present in the same type of drugs at PharmaTech. In October of that year, the FDA warned health-care professionals not to use any oral liquid docusate sodium manufactured by PharmaTech. The FDA said that it would then continue to monitor any adverse reaction reports.
It is unclear why, nearly a year after the CDC investigation and subsequent recall, distributors recieved access to PharmaTech oral liquid docusate sodium. A spokesperson for the FDA told Drug Topics that the recalls were voluntary, and reiterated that the FDA does not have recall authority over drug products. Major Pharmaceuticals declined to comment, and Rugby has not responded to requests for comments at this time.
For a complete list of recalled products, click here.