The Recall Desk
ModerateFDA (Drugs)·D-0623-2018·Announced 2018-04-18

Elroselabs Recalls Conzerol Hydrogen Peroxide Gel Due to cGMP Deviations

Elroselabs Inc. is voluntarily recalling Conzerol Hydrogen Peroxide Gel 3% nationwide due to current Good Manufacturing Practice (cGMP) deviations.

What this means for you

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 voluntary due to cGMP deviations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/manufacturing errors without reported illness.

Plain-English summary

Elroselabs Inc. is voluntarily recalling Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC. The product was manufactured for Elrose Labs, Inc., located in Sanford, FL. The recall was initiated on March 28, 2018, and is classified as Class II by the FDA.

The reason for the recall is current Good Manufacturing Practice (cGMP) deviations. The recall covers all product within expiry and was distributed nationwide. The recall status is currently Terminated, with a termination date of December 15, 2020.

Consumers who have this product should stop using it and contact the recalling firm for further instructions. The recall was initiated by the firm and notified via letter.

The recalled product

Product
Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL
Manufacturer
Elroselabs Inc.
Category
Drug — OTC Topical
Hazard

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 product within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Elroselabs Inc. 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 3 products in this recall →

Related recalls

Same manufacturer · Elroselabs Inc.

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Same hazard · cGMP deviation

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