FDA-Drug2017-08-30Class II

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

The Harvard Drug Group
Hazard

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Sold states
Nationwide in the USA
Affected count
7,272 bottles
Manufactured in
17177 N Laurel Park Dr Ste 233, Livonia, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1120-2017

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