D-1129-2017 Class II Terminated

Recalled by Degasa Sa De Cv — Jiutepec, N/A

FDA drug recall D-1129-2017 was initiated by Degasa Sa De Cv on Aug 4, 2017 and is designated Class II. 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. The recall status is terminated (terminated Nov 24, 2020). Affected quantity: 720 bottles.

Recall Details

Product Type
Drugs
Report Date
Sep 13, 2017
Initiation Date
Aug 4, 2017
Termination Date
Nov 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
720 bottles

Product Description

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.

Distribution Pattern

CA, IL.

Code Information

Lot #: 3A176011, Exp 10/18

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1129-2017
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1129-2017. Report a data issue: hello@regdatalab.com.