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.
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: 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
- manufacturing-defect
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.
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