Diocto FDA Alerts
The FDA Alerts below may be specifically about Diocto or relate to a group or class of drugs which include Diocto.
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.
Recent FDA Alerts for Diocto
Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination
[Posted 08/10/2017]
ISSUE: The distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories jointly issued a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.
Through recent communication with FDA, the distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC. The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions). In response, Rugby Laboratories issued a voluntary recall on August 3, 2017, of the PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC.
See the press release for a list of affected products.
BACKGROUND: The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies.
RECOMMENDATION: The distribution firms are notifying their distributors and customers by recall letter and are arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.
Consumers with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 a.m. – 8 p.m. EST or Leader Customer Support at 1-800-200-6313 option #1 Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m. – 5 p.m EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.
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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[08/10/2017 - Press Release]
Related MedWatch Alerts:
[08/03/2017 - Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination]
Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use
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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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]
Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination
[Posted 08/03/2017]
ISSUE: Rugby Laboratories is voluntarily recalling all lots of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC due to a risk of product contamination with Burkholderia cepacia. FDA informed Rugby that it received several adverse event reports of B. cepacia infections in patients which may be linked to Diocto Liquid or Diocto Syrup manufactured by PharmaTech LLC.
If a product contains B. cepacia, its use 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 in the at-risk patient population.
All lots with NDC 0536-0590-85 and NDC 0536-1001-85 are included in this recall.
BACKGROUND: Diocto Liquid and Diocto Syrup are used as stool softeners and are packaged in one pint (473 mL) bottles. Diocto Liquid was distributed nationwide to wholesale and retail facilities including hospitals and pharmacies.
RECOMMENDATION: Rugby Laboratories 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 the product immediately.
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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[08/02/2017 - Press Release - Rugby Laboratories]
Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination
ISSUE: PharmaTech, LLC is voluntarily recalling all liquid products due to a potential risk of product contamination with Burkholderia cepacia. See the press release for a complete listing of affected products.
Drug products include:
Aller-chlor Antihistamine
Diocto Syrup
Docusate Sodium
Ninjacof
Ninjacof A
Senexion Liquid
Senna Syrup
Sennazon Syrup
Virtrate-2
Virtrate-K
Dietary supplement products include:
Calcionate Syrup
Cerovite Liquid
CertaVite with Antioxidants
CytoDetox
D3 Vitamin Liquid
D-Vita Drops
Fer-iron Liquid
Ferrous Drops
Ferrous Sulfate Liquid
Liquid Vitamin C
Pedia D-Vite Drops
Pedia Poly-Vite Drops
Pedia Tri-Vite Drops
Poly-Vita Drops
Poly-Vita Drops with Iron
Polyvitamin liquid
Polyvitamin liquid with Iron
Renew HC
Tri-Vita Drops
Tri-Vitamin liquid
If a product contains B. cepacia, its use 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 in the at risk patient population.
BACKGROUND: This recall affects all liquid products from October 20, 2015 through July 15, 2016.
RECOMMENDATION: PharmaTech, LLC 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.
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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[08/08/2016 - Press Release - PharmaTech]
Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. cepacia
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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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]