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Recall Observatory FDA recall evidence

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

August 08, 2016

Class II

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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations