The National Agency for Food and Drug Administration and Control have been informed that the Rugby Laboratories of Livonia MI, on 3rd August, 2017 recalled lots of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by Pharma Tech, LLC of Davie, FL, due to risk of product contamination with Burkholderiacepacia. The use of products containing B.cepacia 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.
Diocto Liquid and Diocto Syrup are used as stool softeners and 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.
Healthcare Providers, facilities and consumers in possession of Diocto Liquid 50mg/5ml NDC 0536-0590-85 or Diocto Syrup 60mg/15ml NDC 0536-1001-85 for all lots within the expiration period should immediately stop the dispensing and use of the products and report all adverse events resulting from the consumption of the product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng.
NAFDAC…………Safeguarding the health of the Nation
