The Food and Drug Administration (FDA) is alerting providers about a voluntary recall of Diocto liquid and syrup because of a risk of contamination with Burkholderia cepacia.
The product is used as a stool softener, and a B. cepacia contamination could cause serious or life-threatening infections in patients with compromised immune systems or chronic lung conditions.
The affected lots, produced by by Rugby Laboratories, include NDC 0536-0590-85 and NDC 0536-1001-85. FDA urges health care professionals to immediately stop using and discard these products and to report adverse reactions or quality problems associated with these injections to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.
Contact Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.