The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
FDA is alerting health care professionals and consumers of PharmaTech’s voluntary recall expansion to include all liquid products due to possible Burkholderia cepacia contamination. These products were manufactured in its Davie, Florida, facility, and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
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.
FDA and CDC will provide additional information when it is available.
For more information, please visit: PharmaTech’s voluntary recall.