Gasco Industrial Corp. — Class II: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco In
Gasco Industrial Corp. has initiated a Class II recall for its Gasco Isopropyl Alcohol 70% in 1-gallon containers due to the product being subpotent. The recall status is currently listed as ongoing.
This affects Gasco Industrial Corp., distributors of this specific isopropyl alcohol product, and facility managers or healthcare providers using this product for sanitization or topical preparation.
A subpotent isopropyl alcohol solution may not provide the required level of antimicrobial activity, potentially leading to ineffective disinfection or skin preparation. For regulatory professionals, this underscores the importance of finished product testing and potency verification in topical OTC or USP-grade drug manufacturing. This recall suggests a possible lapse in manufacturing controls or stability monitoring at the Puerto Rico facility.
QA teams should verify that all batches of 70% Isopropyl Alcohol from this manufacturer are quarantined. Manufacturing and facility management should assess whether this product was used for environmental disinfection, as subpotency could compromise sanitization protocols. Check inventory for the specific 1-gallon format.
Class II. Reason: Subpotent drug. Product: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA. Firm: Gasco Industrial Corp. (Gurabo PR United States). Status: Ongoing.
Open in openFDA / FDA.gov