PharmaTech Oral Liquid Products – Potential contamination with Burkholderia cepacia (Expanded Recall)
August 11, 2016
PharmaTech and FDA have expanded the recall of oral liquid products due to potential contamination with Burkholderia cepacia. The initial recall and MedWatch alert were only for docusate oral liquid products. The expanded recall includes all liquid oral products manufactured by PharmaTech, LLC. Both FDA and CDC warn against using any oral liquid docusate product from any manufacturer because they have been implicated in a multistate outbreak of B cepacia infections. To date, CDC has confirmed 60 cases of B cepacia across 8 states. Report any case of B cepacia in hospitalized patients without cystic fibrosis immediately to infection control personnel. Even though infections from B cepacia can occur in patients with cystic fibrosis, healthcare professionals should report multiple cases to local or state public health departments. Docusate enemas and oral capsules do not appear to be affected. No cases of B cepacia related to PharmaTech products other than docusate have been reported to FDA.
PharmaTech LLC recalled its liquid docusate product due to confirmed B cepacia contamination. This product is distributed by Rugby Laboratories as Diocto Liquid. Docusate products from other manufacturers have also been linked to B cepacia infections. FDA and CDC are working to determine other manufacturers whose products may be contaminated. PharmaTech LLC is now recalling all its liquid products from October 20, 2015, through July 15, 2016, as a precaution due to potential contamination with B cepacia. These products are distributed by various companies including Rugby, Major, Bayshore, Centurion, Metron, and Virtus. Please see the Safety Alert (dated August 9, 2016) or Press Release (dated August 8, 2016) linked below for a complete list of affected products.
CDC is continually updating their website as new information becomes available about the B cepacia outbreak. Please visit http://www.cdc.gov/hai/outbreaks/b-cepacia/index.html for more details. Questions regarding this outbreak can be sent to CDC at email@example.com. Report adverse events or quality issues with oral liquid products to the FDA MedWatch program at www.fda.gov/medwatch/report.htm. For questions about the complete PharmaTech recall, call 754-701-8320.
- MedWatch Safety Alert – August 9, 2016
- FDA Press Release – August 8, 2016
- FDA Drug Safety Communication – July 15, 2016
- FDA Drug Safety Communication – July 16, 2016; updated August 9, 2016
- Centers for Disease Control and Prevention – Multistate Outbreak of Burkholderia cepacia Infections – July 16, 2016
- MedWatch Safety Alert – July 16, 2016
August 11, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.