The Recall Desk
ModerateFDA (Drugs)·D-0003-2018·Announced 2017-10-11

Inopak Recalls Mild Healthcare Antibacterial Hand Soap Due to Contamination Risk

Inopak Ltd is recalling specific batches of Mild Healthcare Antibacterial Hand Soap due to potential bacterial contamination from a defective pump.

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 involves a voluntary precautionary measure for potential contamination without reported illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary recalls.

Plain-English summary

Inopak Ltd is voluntarily recalling specific batches of Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X. The affected products are available in 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles. The recall covers Batch Numbers 6749 and 6909, which were distributed nationwide.

The recall was initiated due to Good Manufacturing Practice (GMP) deviations. The company identified that a contaminated diaphragm pump may have introduced bacterial contamination into the product. No illnesses or injuries have been reported in connection with these products.

Consumers and healthcare facilities should stop using the affected batches and contact Inopak Ltd for further instructions or a refund. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
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 (2)

  • Batch Numbers  6749
  • 6909

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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