Povidone Iodine Solution Recalled for Labeling Error
Degasa Sa De Cv is recalling 720 bottles of Povidone Iodine 10% solution due to a label mix-up where 7.5% product was labeled as 10%.
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 and involves a minor labeling error (concentration mismatch) without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Degasa Sa De Cv is recalling 720 bottles of Povidone Iodine, USP Prep Solution, 10%, packaged in 1-gallon bottles. The recall is due to a labeling error where finished product containing 7.5% Povidone Iodine was incorrectly labeled as 10% Povidone Iodine, although the outer box contained the correct label.
The affected product is identified by Lot # 3A176011 and an expiration date of 10/18. The product was manufactured for PSS World Medical, Inc. and made in Mexico. Distribution was limited to California and Illinois.
Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09
- Manufacturer
- Degasa Sa De Cv
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 720
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 #: 3A176011
- Exp 10/18
Distribution
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