Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1569-2020·Announced 2020-09-09

AAA Cosmetica Recalls bio aaa Advance Hand Sanitizer Due to CGMP Deviations

AAA Cosmetica is voluntarily recalling 21,228 bottles of bio aaa Advance Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations.

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 due to CGMP deviations, which typically indicates a remote risk of temporary or medically reversible health consequences, fitting the Moderate severity criteria for voluntary precautionary recalls without reported illness.

Plain-English summary

AAA Cosmetica, SA de CV is voluntarily recalling 21,228 bottles of bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL). The recall was initiated on July 2, 2020, and is classified as Class II by the FDA. The product was distributed nationwide in the USA by Payless Janitorial Corporation.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots include 20DF9005 and 20DF9006, with an expiration date of April 2022. The product is identified by UPC 7 502272 12111 5.

Consumers who have this product should stop using it and contact the distributor or manufacturer for further instructions. The recall status is currently terminated.

The recalled product

Product: bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
Manufacturer: AAA Cosmetica, SA de CV
Category: Drug — Hand Sanitizer
Hazard: cgmp-deviations
Affected units: 21,228

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 (3)

Lots: All lots to include 20DF9005
20DF9006
EXP April 2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AAA Cosmetica, 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 · AAA Cosmetica, SA de CV

See all →

Critical
Hand Sanitizer Recalled for Methanol Contamination
FDA (Drugs) · 2020-09-09

Same hazard · cgmp deviations