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

FDA recall notice · announced August 30, 2017 · The Harvard Drug Group

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: Item# 370282, Lot: 22941701
Quantity: 7,272 bottles
Status: Terminated
Products in this recall event:
- 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 --- N (D-1119-2017)
- Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- N (D-1122-2017)
- Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 0 (D-1121-2017)
- Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- (D-1123-2017)
- 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 (D-1120-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.