The Recall Desk
ModerateFDA (Drugs)·D-1525-2016·Announced 2016-10-05

Pharmatech Recalls Senexon Liquid Due to Potential B. cepacia Contamination

Pharmatech LLC is recalling Senexon Liquid (sennosides) 8.8 mg bottles nationwide as a precautionary measure due to a potential risk of contamination with B. cepacia bacteria.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is described as a precautionary measure due to a potential risk of contamination. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.

Plain-English summary

Pharmatech LLC is recalling 96,704 bottles of Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL). The product is distributed by Rugby Laboratories and is available nationwide. The recall covers specific lots with expiration dates ranging from August 2017 to June 2018.

The recall was initiated as a precautionary measure due to Current Good Manufacturing Practice (CGMP) deviations that created a potential risk of product contamination with the bacteria B. cepacia. The source text does not report any illnesses or injuries associated with this recall.

Consumers with this product should check their bottles for the affected lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

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.
Manufacturer
Pharmatech LLC
Affected units
96,704

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Pharmatech LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →