The Recall Desk
SevereFDA (Drugs)·D-0002-2018·Announced 2017-10-11

Inopak Recalls Antibacterial Hand Wash Due to Potential Bacterial Contamination

Inopak Ltd is recalling Option Systems and STYLE Antibacterial Hand Wash due to GMP deviations and potential bacterial contamination from a pump.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination or significant injury risks, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

Inopak Ltd is voluntarily recalling specific batches of Option Systems Antibacterial Foaming Hand Wash and STYLE Antibacterial Hand Soap. The recall is being conducted due to Good Manufacturing Practice (GMP) deviations that may have allowed bacterial contamination to be introduced to the products through a contaminated diaphragm pump.

The affected products include 8 fl oz and 18 fl oz bottles, as well as 500 mL, 800 mL, and 1000 mL pouches. The recall covers specific batch numbers for both the Option Systems and STYLE brands, which were distributed nationwide.

Consumers who have purchased these products should stop using them and contact Inopak Ltd for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
Manufacturer
Inopak Ltd
Category
Drug — Topical Antiseptic
Hazard

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)

  • Batch Numbers  6718
  • 6730
  • 6744
  • 6754
  • 6760
  • 6773
  • 6784
  • 6793
  • 6804
  • 6812
  • 6819
  • 6838
  • 6846
  • 6862
  • 6877
  • 6890
  • 6902
  • 6910
  • 6919
  • 6938

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Inopak Ltd 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 3 products in this recall →

Related recalls

Same manufacturer · Inopak Ltd

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Same hazard · bacterial contamination

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