PharmaTech, LLC announced a voluntary recall all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.

Scanning Electron Micrograph of Burkholderia cepacia/CDC
Scanning Electron Micrograph of Burkholderia cepacia/CDC

These products were manufactured in its Davie, Florida, facility, and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus. See the list of products HERE

Consumers, pharmacies, and health care facilities that have product which is being recalled should stop using and dispensing them immediately. Using these products in a patient whose immune system is compromised could result in infections, which may be life-threatening.
To date, FDA has received adverse event reports related to oral liquid docusate sodium and is not aware of any adverse event reports related to the additional recalled products.

This is an expanded recall from the one in July when the company recalled all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan.

To date, the Centers for Disease Control and Prevention (CDC) has confirmed 60 cases from 8 states in the outbreak. This issue remains under investigation.

If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at risk patient population.

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