Povidone Iodine — Class II drug recall D-1129-2017
Terminated recall by Degasa Sa De Cv, reported 2017-09-13, distributed in CA, IL. Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer b
| Recall number | D-1129-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Degasa Sa De Cv, Jiutepec, N/A, Mexico |
| Recall initiated | 2017-08-04 |
| Classified | 2017-09-07 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2020-11-24 |
| Distributed | CA, IL |
| Quantity | 720 bottles |
| Reason classes | labeling |
| NDC | 68345-0350-09 |
| Lot numbers | 10/18, 3A176011 |
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
Reason for recall
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1129-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.