Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations
Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were 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, injuries, or specific contamination hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Inopak Ltd is voluntarily recalling specific batches of ANTIBACTERIAL Foaming Hand Wash With Moisturizers, which are labeled as Antibacterial Foaming Soap. The product contains P.C.M.X as an active ingredient and is distributed in various package sizes, including 18 oz bottles, 1 gallon bottles, and 1000mL pouches. The recall covers batches 6657 through 7411, with each batch weighing 17,850 pounds.
The recall was initiated because the hand sanitizers and soaps were not produced under current good manufacturing practices (CGMP). This deviation from required manufacturing standards necessitates the removal of the product from the market to ensure compliance with safety regulations.
The affected products were distributed nationwide in the USA. 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
- ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming…
- Manufacturer
- Inopak Ltd
- Category
- Drug — 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 #: 6657
- 6666
- 6671
- 6679
- 6687
- 6695
- 6702
- 6718
- 6730
- 6744
- 6754
- 6760
- 6772
- 6773
- 6784
- 6793
- 6804
- 6812
- 6819
- 6838
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 →Related recalls
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