Medline Recalls Subpotent Povidone-Iodine Scrub Solution Bottles
Medline Industries is recalling 67,104 bottles of Povidone-Iodine Scrub Solution because the product failed to meet required iodine levels.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a subpotent drug (failure to meet potency requirements) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Medline Industries Inc. is recalling 67,104 bottles of Povidone-Iodine Scrub Solution, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ. The product is identified by Lot # 16EJ0023 and has an expiration date of 04/18. The recall was initiated because the product is subpotent, meaning it does not meet the iodine assay level requirements through the labeled expiry date.
The affected product was distributed nationwide in the USA and in Curacao. It is manufactured in the USA by Medline Industries, Inc., located in Northfield, IL. The specific product number is MDS093945 and the NDC is 53329-938-04.
Consumers should check their inventory for this specific lot number and expiration date. If they have the affected product, they should stop using it and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- POVIDONE-IODINE (POVIDONE-IODINE)
- Brand
- POVIDONE-IODINE
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Topical Antiseptic
- Affected units
- 67,104
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 (2)
- Lot #: 16EJ0023
- Exp 04/18
Distribution
Distributed nationwide across the United States.
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