The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0161-2021·Announced 2020-12-23

CitruGel Hand Sanitizer Recalled for Subpotent Drug Content

Simex Logistics SA de CV is voluntarily recalling 1,800 bottles of CitruGel Hand Sanitizer because the product is subpotent.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a subpotent drug, which is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Simex Logistics SA de CV is voluntarily recalling 1,800 bottles of CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L). The recall was initiated on November 25, 2020, and was classified as Class II by the FDA. The reason for the recall is that the product is a subpotent drug, meaning it does not contain the full amount of the active ingredient required by its label or the United States Pharmacopeia.

The affected product is identified by Lot 0-620 with an expiration date of 06/10/2023. The product was distributed in California, Georgia, Nevada, and Texas. The recall was initiated by the firm and is voluntary. The recall status is currently terminated as of May 17, 2023.

Consumers who have this product should stop using it and contact the distributor, Citru Gel Inc., or the manufacturer, Simex Logistics SA de CV, for further instructions. The FDA has not reported any illnesses or injuries associated with this recall.

The recalled product

Product
CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01
Manufacturer
Simex Logistics SA de CV
Category
Drug — Hand Sanitizer
Hazard
Affected units
1,800

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 (2)

  • Lot: 0-620
  • Exp 06/10/2023

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 5 recalled by Simex Logistics 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 5 products in this recall →

Related recalls

Same manufacturer · Simex Logistics SA de CV

See all →

Same hazard · subpotent drug

See all →

Similar recalls