FDA Asks Manufacturer Of Iodine Products To Agree To A Recall

H&P Industries, Inc., which manufactures over-the-counter drug products, has agreed with the FDA to recall all of its Providone Iodine Swabsticks, Providone Iodine Prep Solutions, Providone Iodine Scrub Solutions, and Providone Iodine Prep Gel, because of a concern that H&P Industries, Inc. did not have in place a system for microbial testing when the products were manufactured, it did not have a system to test the incoming components, and it did not have procedures designed and established to prevent objectionable microorganisms from contaminating the products. Testing of the finished products by H&P Industries, Inc. did not find any contamination and H&P Industries, Inc. stated that its products met its finished products standards. In addition, H&P claims to not have received any reports regarding adverse events or contamination of these products. The products were distributed in the United States.

The recalled products were labeled as an antiseptic for preparation of skin prior to surgery and are used to prevent infections involving minor cuts, scrapes, and burns. Providone Iodine Scrub is also used as a surgical hand scrub.

Source

Even though H&P Industries, Inc. voluntarily agreed to the FDA’s request for these products to be recalled, and there is presently no evidence that these products were in fact contaminated at any time during the manufacturing process, the fact of this recall emphasizes that the manufacturers of drugs and other pharmaceutical products need to have the required appropriate systems in place during the manufacturing process to insure the safety and purity of their products and they need to conduct the proper testing during the manufacturing process so that the finished products contain only those components that are approved as safe and compliant with the approved manufacturing process.

Just because testing after the products are manufactured do not show contamination or there are no current reports of adverse events associated with the use of the products does not guarantee that the products are safe for use. The safety and the purity of the ingredients of drugs and other pharmaceutical products are greatly enhanced by having proper manufacturing procedures in place and by requiring that the component ingredients are properly tested before the final products are manufactured.

The FDA’s rules and regulations that pharmaceutical manufacturers must strictly comply with before, during, and after the manufacturing process were put in place to reduce the possibility that the final product will contain unsafe or contaminated ingredients. 

Voluntary recalls, such as the one involving the H&P Industries, Inc.’s iodine products listed above, can help reinforce the public’s trust that the pharmaceutical products they purchase and use are of high quality, meet the required specifications, are safe to use as labeled and intended, and are of the highest purity. One area in which most people would not want the manufacturers of consumer goods to be lax would be pharmaceutical items that we rely on to keep us safe and healthy or to nurse us back to health.

Nonetheless, if you suffered adverse consequences or injuries as a result of a defective pharmaceutical product such as a bad drug or other defective product, you may be entitled to compensation for your losses. A medical malpractice attorney may be able to help you determine if you have a valid claim. Visit our website to be connected with medical malpractice lawyers in your area who may be able to assist you with your claim or call us toll free 800-295-3959.

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This entry was posted on Friday, August 26th, 2011 at 10:11 am. Both comments and pings are currently closed.

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