The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1316-2019·Announced 2019-06-05

Inopak Recalls Mild Health Care Antibacterial Hand Soap for CGMP Deviations

Inopak Ltd is recalling Mild Health Care Antibacterial Hand Soap because it was not produced under current good manufacturing practices.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Inopak Ltd is recalling specific batches of Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X. The affected products are packaged in 1000 ml Disc Pump pouches, 2000 ml Disc Pump pouches, 800 ml Universal Valve pouches, and 1 gallon bottles. The recall covers batches 6656, 6959, and 7008, which were distributed nationwide in the USA.

The recall was initiated because the hand sanitizers and soaps were not produced under current good manufacturing practices (CGMP). This deviation from standard manufacturing protocols necessitates the removal of the product from the market.

Consumers who have purchased these specific batches should stop using the product and contact Inopak Ltd for further instructions or a refund.

The recalled product

Product
Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800…
Manufacturer
Inopak Ltd
Category
Drug — Hand Soap / Sanitizer
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 (3)

  • Batch #: 6656
  • 6959
  • 7008

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

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