Rugby Laboratories of Livonia, Mich., is recalling Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech of Davie, Fla.
The products, which are used as stool softeners, may be contaminated with Burkholderia cepacia, which 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.
The Food and drug Administration has informed the firm that it received several adverse event reports of B. cepacia infections in patients which may be linked to the recalled products.
The recalled products are packaged in one pint (473 mL) bottles. All lots with NDC 0536-0590-85 and NDC 0536-1001-85 are included in this recall.
Diocto Liquid was distributed nationwide to wholesale and retail facilities including hospitals and pharmacies.
What to do
Customers who purchased the recalled product should stop using it immediately.
Consumers with questions regarding this recall may contact Rugby's customer support department at 1-800-645-2158, available Monday through Friday 8a – 8p (EST).