Medline Alcohol Prep Pads recalled for subpotent isopropyl alcohol concentration
Medline Alcohol Prep Pads are being recalled nationwide because the isopropyl alcohol concentration is below the labeled amount, reducing product effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a topical antiseptic product with below-labeled isopropyl alcohol concentration. The hazard is reduced antimicrobial efficacy from a formulation error, without reported acute safety incidents, warranting a Moderate severity score.
Plain-English summary
Medline Industries, LP is recalling Medline Alcohol Prep Pads (70% Isopropyl Alcohol) distributed nationwide. The isopropyl alcohol concentration in these products falls below the labeled amount, reducing the antimicrobial efficacy of the prep pads.
The recall includes approximately 6,669,874 sterile 2-ply alcohol prep pads, including product with NDC 53329-811-30 and code 61224040057. Consumers who have purchased these products should discontinue use and contact Medline Industries, LP at 1-800-MEDLINE for additional guidance.
The recalled product
- Product
- MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
- Brand
- MEDLINE ALCOHOL PREP
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Drug — Antiseptic Prep
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 61224040057
Distribution
Distributed nationwide across the United States.
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