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Recall Observatory FDA recall evidence

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

August 04, 2017

Class II

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

    reason.labeling_packaging · v1.0.0

    Labeling: Label mix-up