OralProCare Medicated Lip Treatment Recalled for Manufacturing Specification Deviations
Den-Mat Holdings recalls OralProCare medicated lip treatment due to manufacturing quality control deviations that may affect product conformance to labeled specifications. No illnesses reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates that use may cause adverse health consequences. The manufacturing deviations affecting product specifications in a medicated product represent a risk-of-harm scenario, though no illnesses or injuries have been reported to date.
Plain-English summary
Den-Mat Holdings, LLC, of Lompoc, California, is recalling OralProCare medicated lip treatment due to current Good Manufacturing Practice (cGMP) deviations that may prevent the product from conforming to its labeled specifications. No illnesses or injuries have been reported.
The recalled product is OralProCare medicated lip treatment, 6.0% ethyl alcohol, in 9.9 g tubes, distributed nationwide in the United States. Two affected lot numbers are: 2319500023 (expiration 01-12-2024) and 2330400002 (expiration 11-02-2024). The National Drug Code (NDC) is 59883-500-01.
Consumers in possession of affected product should stop using it and contact Den-Mat Holdings for return or disposal instructions.
The recalled product
- Product
- OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
- Manufacturer
- Den-Mat Holdings, LLC
- Category
- Drug
- 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 (4)
- Lot #s: 2319500023
- Exp: 01- 12-2024
- 2330400002
- Exp: 11-02-2024.
Distribution
Distributed nationwide across the United States.
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