PlainRecalls
FDA Drug Moderate Class II Terminated

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85

Reported: August 30, 2017 Initiated: August 2, 2017 #D-1119-2017

Product Description

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85

Reason for Recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Details

Recalling Firm
The Harvard Drug Group
Units Affected
7,308 bottles
Distribution
Nationwide in the USA
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85. Recalled by The Harvard Drug Group. Units affected: 7,308 bottles.
Why was this product recalled?
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2017. Severity: Moderate. Recall number: D-1119-2017.