Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
DuraPrep Surgical Solution Iodine Povacrylex
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Chemical contamination: Product may be contaminated with a toxic compound.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
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.
Affected NDCs
17518-0011-07
17518-0011-08
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| 3M DuraPrep Surgical Iodine Povacrylex and Isopropyl Alcohol NDC 17518-0011 |
IODINE POVACRYLEX 6.02 mg/mL; ISOPROPYL ALCOHOL 636.4 mg/mL | Solution Topical |
Solventum US LLC | OTC |
- Recalling firm
- 3M Company - Health Care Business
- NDC code
- 17518-0011-08
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1417-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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