Recalls / Class II
Class IID-1525-2016
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.
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recalling firm
- Firm
- Pharmatech LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4131 Sw 47th Ave, Suite 1403, Davie, Florida 33314-4026
Distribution
- Quantity
- 96,704 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-08
- FDA classified
- 2016-09-27
- Posted by FDA
- 2016-10-05
- Terminated
- 2024-09-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1525-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.