CLASS II Drug recall · Reported 13 Sep 2017 · FDA Enforcement Report
Povidone Iodine, USP Prep Solution recalled by Degasa Sa De Cv
Degasa Sa De Cv is recalling Povidone Iodine, USP Prep Solution, 10%, distributed in California, Illinois. The recall was initiated on 4 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1129-2017
- FDA event ID
- 78034
- Recalling firm
- Degasa Sa De Cv, Jiutepec, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2017
- FDA classified
- 7 Sep 2017
- Reported
- 13 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 4 Aug 2017 | Recall initiated by company | |
| 7 Sep 2017 | Classified by FDA | +34 days |
| 13 Sep 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
CA, IL.
Questions about this recall
Is Povidone Iodine, USP Prep Solution, 10% recalled?
Yes. Degasa Sa De Cv recalled Povidone Iodine, USP Prep Solution, 10% on 4 Aug 2017. The recall is Class II and its status is Terminated. Recall number D-1129-2017.
Why was it recalled?
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Which lots are affected?
Lot #: 3A176011, Exp 10/18
Where was it sold?
CA, IL.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.