FDA Drug Class II — Moderate

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

Hazard

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

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
Brand
The Harvard Drug Group
UPC
Item# 370282, Lot: 22941701

Units Affected

7,272 bottles