Zep Inc — Class II: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA
Zep Inc has initiated a Class II recall for its 70% Ethanol Alcohol Sanitizer Spray (55-gallon drums) due to microbial contamination of products labeled as sterile.
This affects Zep Inc, distributors of bulk sanitizers, and industrial or clinical users of the 55-gallon 70% ethanol spray product.
The presence of microbial contamination in a product intended to be sterile represents a significant failure in sterility assurance and manufacturing controls. For regulatory teams, this suggests a need to scrutinize the environmental monitoring and aseptic processing validation for bulk-format over-the-counter drug products.
Quality units should verify the sterility status of any ethanol-based products in inventory under NDC 66949-133-85. Facilities utilizing 55-gallon bulk containers should review their material acceptance procedures for microbial testing requirements.
Class II. Reason: Microbial contamination of sterile products. Product: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.. Firm: Zep Inc (Emerson GA United States). Status: Ongoing.
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