PlainRecalls
FDA Drug Moderate Class II Terminated

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85

Reported: August 30, 2017 Initiated: August 2, 2017 #D-1120-2017

Product Description

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85

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
7,272 bottles
Distribution
Nationwide in the USA
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85. Recalled by The Harvard Drug Group. Units affected: 7,272 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-1120-2017.