Gasco Industrial Corp. — Class II: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drog
Gasco Industrial Corp. has initiated a Class II recall for 32 oz. (946 mL) bottles of Isopropyl Alcohol 70% distributed by Drogueria San Juan due to the product being subpotent. The recall is currently classified as ongoing by the FDA.
This recall affects Gasco Industrial Corp., its distributor Drogueria San Juan, and quality, compliance, and supply chain professionals responsible for the manufacturing and distribution of topical antiseptic drug products.
A Class II classification indicates that the use of or exposure to this subpotent product may cause temporary or medically reversible adverse health consequences. For regulatory professionals, subpotency findings typically suggest issues in the manufacturing process, stability testing, or raw material verification, which may necessitate an investigation into Good Manufacturing Practice (GMP) deviations at the production facility.
QA and QC teams should review current stability testing and batch release protocols for isopropyl alcohol products to ensure stated concentrations are maintained throughout the product lifecycle. Distribution partners should verify inventory against the UPC and sizes identified in the recall notice to secure subpotent stock.
Class II. Reason: Subpotent drug. Product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.. Firm: Gasco Industrial Corp. (Gurabo PR United States). Status: Ongoing.
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