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, Manufactured by PharmaTech LLC, Davie, FL

Reported: January 24, 2018 Initiated: August 16, 2017 #D-0224-2018

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, Manufactured by PharmaTech LLC, Davie, FL

Reason for Recall

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

Details

Recalling Firm
Pharmatech LLC
Units Affected
Unknown
Distribution
MI
Location
Davie, FL

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, Manufactured by PharmaTech LLC, Davie, FL. Recalled by Pharmatech LLC. Units affected: Unknown.
Why was this product recalled?
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Which agency issued this recall?
This recall was issued by the FDA Drug on January 24, 2018. Severity: Moderate. Recall number: D-0224-2018.