Drug product
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
Product summary
- Event
- Event 77869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,272 bottles
- Official record key
drug-enforcement:D-1120-2017
Official wording
Reason: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Code information: Item# 370282, Lot: 22941701
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial contamination