Liquid Docusate Recall
July 14, 2016 – The U.S. FDA issued a nationwide voluntary recall of Diocto Liquid (docusate sodium) oral solution, manufactured by PharmaTech and distributed by Rugby Laboratories. The U.S. Centers for Disease Control and Prevention (CDC) identified over 50 cases of Burkholderia cepacia complex (B. cepacia) bacterial infections in at least five states as a result of Burkholderia cepacia bacteria which were found in samples of Diocto Liquid that were tested by FDA and the CDC.
B. cepacia infections are harmless for most individuals. However, such infections can be severe for patients who are immunocompromised or already seriously ill and Cystic fibrosis patients are especially prone to having lung infections caused by it. Most patients affected by the current outbreak were given a liquid form of the stool softener, docusate, while they were being treated at intensive care units (ICU) of hospitals. CDC and FDA believe that contaminated docusate liquid may be causing the infections. Other forms of docusate (oral capsules, oral tablets and rectal enemas) are not believed to be affected. CDC is asking healthcare providers not to give patients any liquid docusate products. All new cases of B. cepacia should be reported to public health officials. Additionally, all liquid docusate that might be involved should be collected and saved to be tested for contamination.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.