D-1417-2015 Class II Terminated
FDA drug recall D-1417-2015 was initiated by 3M Company - Health Care Business on Aug 6, 2015 and is designated Class II. Reason for recall: Chemical contamination: Product may be contaminated with a toxic compound. The recall status is terminated (terminated Mar 16, 2017). Affected quantity: a) 4460 cases (0.9 fl oz, 26 mL Single Use Applicator, 20 pouches per case), b) 1059 cases (2 fl oz, 6 mL Single Use…
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 16, 2015
- Initiation Date
- Aug 6, 2015
- Termination Date
- Mar 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 4460 cases (0.9 fl oz, 26 mL Single Use Applicator, 20 pouches per case), b) 1059 cases (2 fl oz, 6 mL Single Use Applicator, 50 pouches per case)
Product Description
DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144.
Reason for Recall
Chemical contamination: Product may be contaminated with a toxic compound.
Distribution Pattern
Nationwide, Puerto Rico, and to foreign distribution centers in Dominican Repulbic, Malaysia, Mexico, Panama, Peru, and United Arab Emirates.
Code Information
Lot#: a) 2016-09EE, 2016-09EF, 2016-09EG, Exp 9/30/16; b) 2016-08DC, Exp 8/31/16.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1417-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026