Inopak Recalls Antibacterial Hand Soap Due to Manufacturing Deviations
Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap 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, which typically involves a temporary or medically reversible adverse health consequence. The source cites CGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity rating for a voluntary precautionary recall.
Plain-English summary
Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap. The affected products include DERMA System CARE SaniClenz Antimicrobial Skin Cleanser and MEDI-WASH CHG Anti-Microbial Hand Wash. The recall covers batches 6802, 6803, 6909, and 6655, 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 these products from the market to ensure compliance with safety and quality standards.
Consumers and healthcare facilities should check their inventory for the specific batch numbers listed above. If these products are found, they should be stopped from use and returned to the supplier or disposed of according to local regulations. No specific instructions for consumer action beyond identifying the affected batches are provided in the source text.
The recalled product
- Product
- Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with…
- Manufacturer
- Inopak Ltd
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 (4)
- Batch #: 6802
- 6803
- 6909
- 6655
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.
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