Ecolab Recalls Subpotent Scrub-Stat Chlorhexidine Gluconate Foam Solution
Ecolab is voluntarily recalling 706 bottles of Scrub-Stat 4% Chlorhexidine Gluconate Foam Solution because the product is subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety threat like contamination or injury.
Plain-English summary
Ecolab Inc. is voluntarily recalling 706 bottles of Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%. The affected product is packaged in 800 mL and 1250 mL plastic bottles and is an over-the-counter drug. The recall was initiated on February 12, 2016, and was classified as Class III by the FDA.
The reason for the recall is that the product is subpotent, meaning it does not contain the full amount of the active ingredient required by the label. The affected lots include L041051, L060151, and L061951, with expiration dates in April and June 2017. The product was distributed nationwide, in Puerto Rico, and in Canada.
Consumers who have this product should stop using it and return it to the place of purchase or contact Ecolab Inc. for a refund. The recall was terminated on March 24, 2017.
The recalled product
- Product
- SCRUB-STAT (CHLORHEXIDINE GLUCONATE)
- Brand
- SCRUB-STAT
- Manufacturer
- Ecolab Inc
- Category
- Drug — Antiseptic
- Hazard
- Affected units
- 706
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 (6)
- Lot #: a) L041051
- Exp 04 /17
- L060151
- L061951
- Exp 06 /17
- b) L060151
Distribution
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