Bersih Hand Sanitizer Gel Recalled for cGMP Deviations
Soluciones Cosmeticas, SA de CV is voluntarily recalling Bersih Hand Sanitizer Gel due to cGMP deviations. The product was distributed in the United States.
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 situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses or injuries, and the hazard is related to manufacturing deviations rather than a specific high-risk pathogen or allergen.
Plain-English summary
Soluciones Cosmeticas, SA de CV is voluntarily recalling Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), with blue and green caps. The recall was initiated on July 14, 2020, and was classified as Class II by the FDA. The reason for the recall is cited as cGMP (Current Good Manufacturing Practice) deviations.
The recalled product was distributed by RediBag USA in New Hyde Park, New York, and was available in the United States. The quantity involved is 2,486,400 bottles. The recall covers all lots remaining within their expiry date. The recall was terminated on February 22, 2022.
Consumers who have this product should stop using it and contact the distributor or manufacturer for further instructions. The recall was initiated by the firm and notified via press release.
The recalled product
- Product
- Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
- Manufacturer
- Soluciones Cosmeticas, SA de CV
- Category
- Drug — Hand Sanitizer
- Hazard
- Affected units
- 2,486,400
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 (1)
- All lots remaining within expiry.
Distribution
Distribution scope not specified by the agency.
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