SV Labs Toronto Corporation — Class II: Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63),
SV Labs Toronto Corporation has initiated a Class II recall for Benzoyl Peroxide Wash, USP, 10% in 5 FL OZ and 8.5 FL OZ bottles due to microbial contamination of the topical product.
This recall affects SV Labs Toronto Corporation, the distributor Rugby Laboratories, and quality/regulatory professionals managing over-the-counter topical acne treatments.
A Class II recall for microbial contamination suggests a failure in aseptic processing or preservative system efficacy during manufacturing. For regulatory teams, this highlights the ongoing risk of bioburden in non-sterile topical products and may indicate a need to audit manufacturing site sanitation and raw material testing protocols.
Quality units should verify if affected NDCs are in their current supply chain, initiate quarantine protocols if necessary, and review microbial testing logs for topical drug manufacturing batches to ensure adherence to USP standards.
Class II. Reason: Microbial contamination of topical product.. Product: Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152.. Firm: SV Labs Toronto Corporation (Brampton Canada). Status: Ongoing.
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