FDA-Drug2016-10-19Class I

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

The Harvard Drug Group
Hazard

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

Sold states
Nationwide
Affected count
153,432 bottles
Manufactured in
31778 Enterprise Dr, N/A, Livonia, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2017

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