Rugby Diocto Liquid recalled over mold contamination

Recall date

August 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharmatech LLC recalls Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:…

Recall number

D-0224-2018

FDA classification

Class II

Brand / firm

Pharmatech LLC

Sold / distributed

MI

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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