Lantiseptic Skin Protectant Recalled Due to Facility Manufacturing Deviation
DermaRite Industries is recalling Lantiseptic Skin Protectant nationwide due to manufacturing practice deviations at a facility where contamination was found in other product lots.
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: This is an FDA Class II recall with a confirmed manufacturing facility contamination issue affecting other product lots; however, no specific contaminant, reported illnesses, or injuries are identified for this product, placing it at the 'High' severity level per the rubric.
Plain-English summary
DermaRite Industries, LLC is recalling Lantiseptic Skin Protectant, a topical skin protectant containing 30% lanolin, packaged in five tube sizes: 5g, 14.2g, 4oz, 4.5oz, and 12oz. The recall affects approximately 57,837 units distributed nationwide in the USA.
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation identified at the manufacturing facility. Other products and lots made at the same facility were found to be contaminated, triggering this precautionary recall of Lantiseptic with expiration dates on or before August 2027.
Consumers who have purchased this product should discontinue use. Those with questions about whether their product is affected should contact DermaRite Industries, LLC or consult their healthcare provider.
The recalled product
- Product
- Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical Skin Protectant
- Hazard
- contamination
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 (1)
- All lots on or before expiry date 08/2027
Distribution
Distributed nationwide across the United States.
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