The Recall Desk
SevereFDA (Drugs)·D-0117-2021·Announced 2020-12-16

FDA Recalls Protz Antibacterial Hand Sanitizer for CGMP Violations

Asiaticon, SA de CV is recalling 111,500 units of Protz Antibacterial Hand Sanitizer distributed in Texas due to a lack of Current Good Manufacturing Practices (CGMPs).

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is 'Class II'. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and never go below 4.

Plain-English summary

Asiaticon, SA de CV is voluntarily recalling 111,500 units of Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL). The product was distributed in Texas by Safety-Med Products, Inc. The recall covers all lots of the product.

The recall was initiated because the product was manufactured without adhering to Current Good Manufacturing Practices (CGMPs). The FDA classified this recall as Class II, which indicates a violation of labeling or CGMPs that may cause temporary or medically reversible health consequences.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The recall was initiated on August 25, 2020, and was terminated on May 17, 2023.

The recalled product

Product
Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019
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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