The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0446-2023·Announced 2023-03-15

Drug Recall: Alcolado Relampago Topical for Manufacturing Practice Deviations

Ecometics recalls Alcolado Relampago topical product nationwide due to Current Good Manufacturing Practice deviations. About 18,000 bottles in 7 oz and 16 oz sizes were distributed in the U.S.

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: FDA Class II recall initiated voluntarily by the manufacturer for Current Good Manufacturing Practice deviations. No illnesses or injuries were reported, and the recall is based on process compliance issues rather than a specific identified product hazard.

Plain-English summary

Ecometics, Inc. is recalling Alcolado Relampago, a topical product containing 1% menthol and 1.5% camphor, distributed nationwide by The Larkspur Group Inc. in South Norwalk, Connecticut. The recall affects 18,000 bottles in two sizes: 7 fluid ounces (207 ml) and 16 fluid ounces (472 ml). The affected lot numbers are 2E018A, 2E021A, and 2E286A, with an expiration date of January 2025.

The recall was initiated on February 24, 2023, due to deviations from Current Good Manufacturing Practice (CGMP) standards. This is a voluntary recall initiated by the manufacturer. The FDA classified this as a Class II recall on March 8, 2023, and the recall was terminated on June 21, 2023.

Consumers should stop using the recalled product. Those who have purchased Alcolado Relampago with the affected lot numbers should check the product code and contact Ecometics, Inc. or The Larkspur Group Inc. for further information.

The recalled product

Product
Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854
Manufacturer
Ecometics, Inc.
Category
Drug — Topical
Hazard
Affected units
18,000

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 (4)

  • Lot #: a) and b) 2E018A
  • 2E021A
  • 2E286A
  • Exp. date Jan-25

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Ecometics, 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 7 products in this recall →

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