Bacterial Contamination (B. cepacia) Leads to Product Recall

PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination

For Immediate Release

July 15, 2016

Contact

Consumers

Rugby®’s Customer Support Department
1-800-645-2158

Media

Brett Ludwig
(215) 970-0153

Announcement

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PharmaTech LLC of Davie, FL, the manufacturer of the Rugby® – branded product, is voluntarily recalling all lots within the expiry of Diocto Liquid, a docusate sodium solution due to a risk of product contamination with Burkholderia cepacia. Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.

As part of its commitment to patient safety, Rugby® Laboratories is working with PharmaTech LLC to notify customers who may be in possession of Diocto Liquid NDC 0536-0590-85; 50 mg/5 mL for all lots within the expiration period.

Diocto Liquid is used as a stool softener and is packaged in one pint (473 mL) bottles. All lots with NDC 0536-0590-85 are included in the recall. Diocto Liquid was distributed nationwide to wholesale and retail facilities including hospitals and pharmacies. The company learned of the potential issue through the receipt of two isolated complaints regarding this product.  FDA has informed PharmaTech and Rugby that it received several adverse event reports of B. cepacia infections in patients.  Additionally, some of these reports identify liquid docusate products manufactured by companies other than PharmaTech.

PharmaTech is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.

 

COMMENT:

B. cepacia represents a bacterium (Click Here) that has often been cited as a “problem microorganism”.  Although discussions have been held within the USP Expert Microbiology Committee and the possibility of adding it as a specified microorganism within USP<62>, this has not occurred.  However, its presence within non-sterile products, even stool softeners, suggests that the facilities that manufacture such products are in need of a total environmental microbiological review to determine the potential source of this microbe.  Ironically, some reports identify liquid docusate products manufactured by companies other than PharmaTech.