Drug product
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: 00904-6289-09
D-1121-2017
Product summary
- Event
- Event 77869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,891 bottles
- Official record key
drug-enforcement:D-1121-2017
Official wording
Reason: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Code information: Item # 263923, all lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial contamination