FDA (Drugs) recall action 88326
The FDA (Drugs) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
SubPotent: Out of Specification
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.
Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.
Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.
Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.
Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.
Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.
Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.