The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1098-2023·Announced 2023-08-30

ALCOLADO RELAMPAGO topical liniment recalled for manufacturing process violations

Ecometics, Inc. is recalling ALCOLADO RELAMPAGO (menthol and camphor) topical liniment nationwide due to manufacturing process deviations. Products were not manufactured under current good manufacturing practices.

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: This is an FDA Class II recall based on manufacturing practice deviations. No illnesses, injuries, or deaths have been reported in the source material. The recall is precautionary in nature, triggered by CGMP violations rather than documented safety incidents.

Plain-English summary

Ecometics, Inc. is recalling ALCOLADO RELAMPAGO, a menthol and camphor topical liniment, due to manufacturing process deviations. The product was distributed nationwide in 7 fluid ounce (207 ml) and 16 fluid ounce (472 ml) bottle sizes by The Larkspur Group, Inc., Norwalk, Connecticut.

The products were not manufactured under current good manufacturing practices (CGMP). Current good manufacturing practices are FDA requirements that ensure products are produced with appropriate quality controls and procedures.

The recall includes multiple lot codes with expiration dates from October 2023 through May 2024. Consumers who have purchased this product should discontinue use immediately.

The recalled product

Product
ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
Manufacturer
Ecometics, Inc.
Category
Drug — Topical Liniment
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 (9)

  • a) 0E280A
  • exp 10/23
  • 0E318A
  • exp 11/23
  • 1E109A
  • exp 3/24
  • 1E141A
  • exp 5/24
  • b) 0E280A

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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