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.
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: 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, Levittown
- Manufacturer
- Ecometics, Inc.
- Category
- Drug — Topical Ointment
- Hazard
- manufacturing-deviation
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.
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