PlainRecalls
FDA Drug Critical Class I Terminated

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

Reported: October 19, 2016 Initiated: July 15, 2016 #D-0022-2017

Product Description

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

Reason for Recall

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

Details

Recalling Firm
The Harvard Drug Group
Units Affected
153,432 bottles
Distribution
Nationwide
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85. Recalled by The Harvard Drug Group. Units affected: 153,432 bottles.
Why was this product recalled?
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Which agency issued this recall?
This recall was issued by the FDA Drug on October 19, 2016. Severity: Critical. Recall number: D-0022-2017.