Agency classClass IIOur severity:Severe FDA (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).

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Asiaticon, SA de CV
Category: Drug — Hand Sanitizer
Hazard: cgmp-violation
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 →

Same manufacturer · Asiaticon, SA de CV

See all →

Moderate
V-Klean Hand Sanitizer Gel Recalled for CGMP Violations
FDA (Drugs) · 2020-12-16

Same hazard · cgmp violation