The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0448-2023·Announced 2023-03-15

FDA Recalls Unguentine Original Ointment for Manufacturing Practice Deviations

Ecometics, Inc. has voluntarily recalled Unguentine Original Ointment for Burns due to manufacturing practice deviations. The recall affects 20,746 units distributed nationwide.

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: Voluntary Class II drug recall with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing practice deviation without a specific identified health threat. Classification as precautionary with termination upon corrective action.

Plain-English summary

Ecometics, Inc. has voluntarily recalled Unguentine Original Ointment for Burns in 1 oz. metal tubes due to deviations from Current Good Manufacturing Practice (CGMP) standards. The topical burn treatment contains Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, and Oxide 6.6%.

The recall was initiated due to manufacturing process deviations that may affect product quality. The FDA classified this as a Class II recall, indicating the deviations may cause adverse health consequences.

The affected product is identified by Lot # 2E116A with expiration date April 2024. Approximately 20,746 units were distributed nationwide throughout the United States. The recall was terminated on June 21, 2023.

Consumers who have this product should stop using it. If you have health concerns or believe you were affected by this product, contact your healthcare provider.

The recalled product

Product
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Manufacturer
Ecometics, Inc.
Category
Drug
Hazard
Affected units
20,746

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 # 2E116A
  • Exp. Date APR-24

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 →

Related recalls

Same manufacturer · Ecometics, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls