Iodine is routinely used on patients ahead of operations to help protect against bacteria contamination. But what if the iodine itself is contaminated with a toxic chemical? That is the issue facing 3M ($MMM), which is recalling thousands of cases of surgical applicators.
According to the most recent FDA Enforcement Report, 3M last month began a voluntary recall of 5,519 cases of DuraPrep Surgical Solution iodine povacrylex and isopropyl alcohol skin preparation. The FDA was not specific about the source of the problem, saying only that the products "may be contaminated with a toxic compound."
This is at least the second time this year for iodine products to become suspect. The European Medicines Agency in March banned products from a Chinese iodine maker after French inspectors turned up contamination issues at its plant in Huzhou, Zhejiang Province. In that case, the inspectors documented 27 deficiences against Huzhou Sunflower Pharmaceutical that included issues with its purified water system and data integrity questions.
3M, which also makes a variety of drug delivery products, has faced recalls before. Last year, Teva ($TEVA) recalled nearly 258,000 cylinders of its inhaled asthma drug Qvar manufactured for it by 3M Drug Delivery Systems because the drug failed stability testing for impurity and degradation specifications at both the 9-month and 18-month time periods.
- here's the FDA recall notice