Gasco Industrial Corp. — Class II: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR
Gasco Industrial Corp. has initiated a Class II recall for a specific lot of Isopropyl Alcohol 70% in 32 oz containers due to the product being identified as a subpotent drug.
The recall affects Gasco Industrial Corp., its distributors, and professional quality and compliance personnel responsible for managing antiseptic or topical drug manufactured lots.
A Class II recall for subpotency indicates that the product fails to meet its labeled strength specifications, which may reduce its efficacy as an antiseptic. Regulatory teams should view this as a failure in manufacturing controls or stability monitoring, potentially requiring a review of assay validation or storage conditions.
QA/QC departments should review current stability testing and potency assay protocols for isopropyl alcohol products to ensure specifications are met throughout the shelf life. Verification of batch records and raw material sourcing may be necessary to identify the root cause of the subpotency.
Class II. Reason: Subpotent drug. Product: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.. Firm: Gasco Industrial Corp. (Gurabo PR United States). Status: Ongoing.
Open in openFDA / FDA.gov