Drug product
Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.
D-1525-2016
Product summary
- Firm
- Pharmatech LLC
- Event
- Event 74874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96,704 bottles
- Official record key
drug-enforcement:D-1525-2016
Official wording
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot #: 20391515, 20391516, Exp 08/17; 20391517, Exp 09/17; 20391518, Exp 10/17; 20391520, Exp 11/17; 20391521, Exp 12/17; 20391601, Exp 01/18; 20391603, 20391604, Exp 03/18; 20391606, 20391607, Exp 04/18; 20391609, Exp 06/18.
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations