Drug 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
D-1129-2017
Product summary
- Firm
- Degasa Sa De Cv
- Event
- Event 78034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720 bottles
- Official record key
drug-enforcement:D-1129-2017
Official wording
Reason: Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Code information: Lot #: 3A176011, Exp 10/18
Distribution pattern: CA, IL.
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up