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Surfak Stool Softener FDA Alerts

The FDA Alert(s) below may be specifically about Surfak Stool Softener or relate to a group or class of drugs which include Surfak Stool Softener (docusate).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for docusate

Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

Aug 8, 2017

Audience: Pharmacy, Patient, Health Professional

ISSUE: FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products – Diocto Liquid and Diocto Syrup, both oral liquid docusate products – manufactured by PharmaTech.

Additional liquid drug products manufactured by PharmaTech might also be affected. Such products might have been labeled and distributed by Rugby and other companies. Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator.

Centers for Disease Control and Prevention laboratory testing of PharmaTech’s oral liquid docusate detected a strain of B. cepacia, bacteria linked to recent patient infections. Therefore, FDA recommends health care professionals and patients not use PharmaTech’s liquid drug products.

BACKGROUND: In 2016, FDA advised health care professionals and patients not to use liquid docusate drug products manufactured at PharmaTech’s Davie, Florida, facility after being implicated in CDC’s public health investigation. These products were labeled and distributed by multiple companies, including Rugby. An FDA investigation associated with a 2016 multistate outbreak identified B. cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment. The 2016 investigation also detected B. cepacia in the water system used to manufacture the product.

RECOMMENDATION: Patients, pharmacies, and health care facilities should immediately stop using and dispensing all liquid products manufactured by PharmaTech. It might be difficult to determine the manufacturer because these liquid products are not labeled with a PharmaTech label. FDA advises health care facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, to check with their supplier to determine the identity of the manufacturer. Patients who are using liquid drug products and who have concerns should contact their health care professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form 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.

[08/08/2017 - Advisory - FDA]

Previous MedWatch Safety Alert:

[08/03/2017 - Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination]
 

Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. cepacia

Jul 16, 2016

Audience: Health Professional

ISSUE: The FDA is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.

BACKGROUND: PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.

RECOMMENDATION: FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.
FDA and CDC will provide additional information when it is available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form 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

[07/16/2016 - CDER Statement - FDA]