Diocto Liquid 50 mg/ Stool Softener Laxative recalled over sterility concerns

Recall date

July 15, 2016

Source

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

Official notice title

The Harvard Drug Group recalls Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laborator…

Recall number

D-0022-2017

FDA classification

Class I

Brand / firm

The Harvard Drug Group

Sold / distributed

Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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