The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1548-2020·Announced 2020-09-02

FDA Recalls Hand Sanitizer Gel Due to Manufacturing Deviations

Resource Recovery & Trading LLC is voluntarily recalling 17,280 bottles of hand sanitizer gel due to cGMP deviations. The product was distributed in Alabama and Georgia.

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 and is a voluntary, firm-initiated action for cGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Resource Recovery & Trading LLC is voluntarily recalling 17,280 bottles of Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol. The product is packaged in 6.7 FL Oz. (200 mL) bottles and distributed by Access USA in Miami, Florida. The recall was initiated on July 27, 2020, and the FDA classified it as Class II.

The reason for the recall is cited as cGMP (current Good Manufacturing Practice) deviations. The affected product was distributed in Alabama and Georgia. All lots are included in this recall.

Consumers who have this product should stop using it and contact the recalling firm for further instructions. The recall status is listed as completed.

The recalled product

Product
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
Affected units
17,280

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 2 states:

Part of a larger recall action

This product is one of 2 recalled by RESOURCE RECOVERY & TRADING LLC 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 · RESOURCE RECOVERY & TRADING LLC

See all →

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