Medications & Supplements/Topical Products

Degasa Sa De Cv: Povidone Iodine Prep Solution Recalled for Labeling Mix-up

Agency Publication Date: September 8, 2017

Summary

Degasa Sa De Cv is recalling 720 bottles of Povidone Iodine, USP Prep Solution (10%) because of a labeling error. While the outer box is correctly labeled, the individual 1-gallon bottles inside are labeled as containing 10% povidone iodine when they actually contain a 7.5% concentration. This over-the-counter antiseptic solution was manufactured for PSS World Medical, Inc. and distributed in California and Illinois.

Risk

A labeling mix-up means the product contains a lower concentration of the active ingredient (7.5% instead of 10%) than what is listed on the bottle. This could lead to ineffective skin disinfection before medical procedures, potentially increasing the risk of infection.

What You Should Do

Check your supply for 1-gallon bottles of Povidone Iodine, USP Prep Solution, 10% with NDC 68345-350-09.
Locate the lot number and expiration date on the bottle to see if it matches Lot #: 3A176011 with an expiration date of 10/18.
If you have an affected bottle, contact your healthcare provider or pharmacist for guidance on how this lower concentration may affect your care.
Return any unused product to the place of purchase for a refund.
Contact Degasa Sa De Cv or PSS World Medical, Inc. for further instructions regarding the return or replacement of these products.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Povidone Iodine, USP Prep Solution, 10% (1 gallon)

Model:

NDC 68345-350-09

Recall #: D-1129-2017

Lot Numbers:

3A176011 (Exp 10/18)

Date Ranges: 10/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78034

Status: Resolved

Manufacturer: Degasa Sa De Cv

Sold By: PSS World Medical, Inc.

Manufactured In: Mexico

Units Affected: 720 bottles

Distributed To: California, Illinois

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your supply for 1-gallon bottles of Povidone Iodine, USP Prep Solution, 10% with NDC 68345-350-09.

Locate the lot number and expiration date on the bottle to see if it matches Lot #: 3A176011 with an expiration date of 10/18.

If you have an affected bottle, contact your healthcare provider or pharmacist for guidance on how this lower concentration may affect your care.

Return any unused product to the place of purchase for a refund.

Contact Degasa Sa De Cv or PSS World Medical, Inc. for further instructions regarding the return or replacement of these products.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.