Drug product
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 --- NDC 0536-1000-59 ; ALSO LABELED AS 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; Manufactured by PharmaTech LLC, Davie, FL
D-0226-2018
Product summary
- Firm
- Pharmatech LLC
- Event
- Event 77960
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0226-2018
Official wording
Reason: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Code information: All lots remaining within expiry.
Distribution pattern: MI
Derived failure modes
-
Microbial contamination
Microbial Contamination