The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1099-2023·Announced 2023-08-30

Unguentine Ointment Recalled Due to Manufacturing Practice Deviations

Ecometics, Inc. is recalling Unguentine Ointment because products were not manufactured under current good manufacturing practices. The recall affects 6,660 tubes 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: FDA Class II recall with no reported illnesses or injuries. The hazard is manufacturing practice deviation without identification of the underlying risk, making this a precautionary recall.

Plain-English summary

Ecometics, Inc. is recalling Unguentine Ointment nationwide because the products were not manufactured under current good manufacturing practices (CGMP) as required by FDA regulations.

The recalled products include Unguentine Ointment Improved Formula (NET WT 1 OZ tubes, UPC 0 11169 10216 0) and Unguentine Ointment Maximum Strength (NET WT 1 OZ tubes, UPC 0 11169 11250 3). All recalled products bear lot code 1E113A with expiration date 4/24. A total of 6,660 tubes were affected (6,120 Improved Formula and 540 Maximum Strength).

No illnesses or injuries have been reported. Consumers with this product should discontinue use and consult their healthcare provider for guidance.

The recalled product

Product
Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company…
Manufacturer
Ecometics, Inc.
Category
Drug — Topical Ointment
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 (2)

  • a) and b) 1E113A
  • exp 4/24

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 deviation

See all →

Similar recalls