The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0160-2021·Announced 2020-12-23

Simex Recalls Subpotent +Protec Hands Antibacterial Gel Topical Solution

Simex Logistics SA de CV is recalling +Protec Hands Antibacterial Gel because it is subpotent. The product was distributed in California, Georgia, Nevada, and Texas.

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 a subpotent drug, which is a minor labeling or potency error without reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Simex Logistics SA de CV is voluntarily recalling approximately 19,340 bottles of +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic. The recall was initiated on November 25, 2020, and the product is classified as FDA Class II. The reason for the recall is that the drug is subpotent, meaning it contains less than the labeled amount of the active ingredient.

The affected product is packaged in 33.8 oz (1000mL) bottles with barcode GOOD-GEL-04062020L and 127.8 oz (3780mL) bottles with barcode 0723707893163. The specific lot number is 0-820, with an expiration date of 07/13/2023. The product was distributed by PS Promotional Services LLC in Dallas, Texas, and was available in California, Georgia, Nevada, and Texas.

Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of it. The recall status is currently terminated as of May 17, 2023.

The recalled product

Product
+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406…
Manufacturer
Simex Logistics SA de CV
Category
Drug — Topical Antiseptic
Hazard
Affected units
19,340

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: 0-820
  • Exp 07/13/2023

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 →

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