The Recall Desk
ModerateFDA (Drugs)·D-0116-2021·Announced 2020-12-16

V-Klean Hand Sanitizer Gel Recalled for CGMP Violations

Asiaticon, SA de CV is voluntarily recalling V-Klean Hand Sanitizer Gel Alcohol 70% due to a lack of Current Good Manufacturing Practices (CGMPs).

What this means for you

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 is a voluntary, firm-initiated recall for a lack of CGMPs. There are no reported illnesses or injuries in the source text, and the hazard is related to manufacturing compliance rather than a specific high-risk pathogen or structural defect.

Plain-English summary

Asiaticon, SA de CV is voluntarily recalling 111,500 units of V-Klean Hand Sanitizer Gel Alcohol 70% in 8.5 fl oz, 16.9 fl oz, and 33.8 fl oz bottles. The recall was initiated because the product was manufactured without adherence to Current Good Manufacturing Practices (CGMPs).

The affected product was distributed in Texas. The recall covers all lots of the product. The recall was initiated on August 25, 2020, and was classified as Class II by the FDA on December 7, 2020.

Consumers who have this product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de
Manufacturer
Asiaticon, SA de CV
Category
Drug — Hand Sanitizer
Hazard
Affected units
111,500

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.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Asiaticon, SA de CV 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 2 products in this recall →

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