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Johnson & Johson’s McNeil Consumer Health division announced recently the recall of many popular over-the- counter children’s liquid medicines. McNeil’s press release lists 43 recalled pediatric medicines affecting 70 percent of the market for OTC children’s medicine. The recall includes Tylenol, Motrin, Zyrtec, and Benadryl, name brands widely used by parents for their children’s pain, cold, and allergy relief.

After concluding a 10-day inspection of McNeil’s Fort Washington, Pa plant where it manufactures all children’s and infants’ Tylenol, Motrin and other popular over-the-counter pediatric medicines, the Food and Drug Administration said that the plant lacked quality controls, used raw materials contaminated with bacteria and failed to investigate consumer complaints that some medicines contained black particles.

FDA officials said that McNeil received 46 consumer complaints between June 2009 and last month about "foreign materials, dark specks" in some medications but that the company failed to determine the cause and correct it. Liquid medicine should be compounded in a sterile environment, free from bacteria and other contaminants. I worked on a series of pharmacy compounding cases a few years ago in which I learned up close the dangers of poor quality control in compounding pharmacies. In those cases, many lots of a blood product used to paralyze the heart during open heart surgery were contaminated. The results for many surgical patients included organ failure and death.

FDA Commissioner Margaret A. Hamburg said parents and caregivers should immediately stop using the recalled medicines. Generic versions are a safe alternative, Hamburg said. A list of recalled products is set forth on McNeil’s press release to which I have linked in the first paragraph. They are also listed along with information about refunds on McNeil’s Web site.

Consumers who seek a refund should NOT agree to return or destroy any recalled product. Should your child become ill from a liquid medicine contaminated by bacteria or other contaminants, you will want to be able to test the product to show that it is the source of the contaminant.

At the Pennsylvania plant, the FDA identified defects in McNeil’s quality-control methods and manufacturing processes, including a failure to track customer complaints and spot trends that may signal systemic problems, a lack of written procedures and a failure to adequately train employees.

Investigators found that raw materials had "known contamination" with unspecified bacteria and "were approved for use to manufacture several finished lots of Children’s and Infant’s Tylenol drug products."

FDA officials said they could not identify the bacteria.

McNeil officials say the portion of raw materials in the medicines were tested and were not contaminated. "However, we understand the FDA’s concern and will be working closely with them to address it," the company said in a statement. "The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us," the statement added.

The company has said that some of the recalled medicines may have a higher amount of active ingredient and that others may contain inactive ingredients that do not meet internal standards.

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