The Recall Desk
ModerateFDA (Drugs)·D-1526-2016·Announced 2016-10-05

Pharmatech Recalls Senna Syrup Due to Potential B. cepacia Contamination

Pharmatech LLC is recalling Senna Syrup due to a precautionary measure regarding potential 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 explicitly described as a 'precautionary measure' due to a 'potential risk' of contamination, with no reported illnesses or injuries in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharmatech LLC is recalling Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. bottles distributed by Major Pharmaceuticals. The recall involves 68,908 bottles with specific lot numbers and expiration dates ranging from September 2017 to June 2018. The product was distributed nationwide.

The recall was initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. This action is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should check their inventory for the affected lot numbers and expiration dates. If you have this product, you should stop using it and contact the recalling firm or a healthcare provider for further instructions.

The recalled product

Product
Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.
Manufacturer
Pharmatech LLC
Affected units
68,908

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 (15)

  • Lot #: 20391517
  • Exp 09/17
  • 20391518
  • Exp10/17
  • 20391519
  • Exp 11/17
  • 20391601
  • Exp 01/18
  • 20391602
  • Exp 02/18
  • 20391604
  • 20391605
  • Exp 03/18
  • 20391608
  • Exp 06/18

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 →