The voluntary recall of 43 over-the-counter infant and children's medications has raised plenty of questions for North Texas parents.
Topping the list of concerns: what to do if a child gets the fever or the sniffles.
The recalled products -- liquid Tylenol, Motrin, Benadryl and Zyrtec -- should have already been removed from store shelves, said Dr. Jason Terk, a Keller pediatrician with the Cook Children's Physicians Network.
"Anything going forward should be OK," he said.
Still, parents should be cautious and make sure they've removed all recalled products from their shelves and stick to generics for now.
The key is products by McNeil Consumer Healthcare, a division of Johnson & Johnson. No others are affected.
Johnson & Johnson may have used bacteria-tainted materials in making the medicines recalled last week, U.S. regulators said.
Food and Drug Administration officials said Tuesday that McNeil failed to protect the drugs from contamination and to correct manufacturing deficiencies at its Fort Washington, Pa., production plant. None of the products tested positive for bacteria, but FDA inspectors found micro-organisms in some raw materials used as inactive ingredients in the drugs, said Deborah Autor, director of compliance at the FDA's Center for Drug Evaluation and Research.
A 17-page FDA report noted that Johnson & Johnson failed to act after 46 consumer complaints were made in the past 10 months about "foreign materials, black or dark specks" in the products.
Agency officials found violations at the plant including a "large exposed hole" in a laboratory ceiling and "a large amount of visible grey and brown dust" and debris inside an incubator. It's too early to say whether additional action is warranted, according to the FDA.
McNeil has said that the potential for serious medical problems is remote and that the recall was not due to adverse medical events. But the company indefinitely shut down its plant where the medications were made.
So what should parents who have trusted these products do to protect their children? A question-and-answer with Terk follows:
What's the problem?
Some of the products may contain a higher concentration of active ingredients than is specified on the label. Some inactive ingredients might not meet internal testing requirements, and others might contain particles.
All of the products of concern -- liquid Tylenol, Motrin, Benadryl and Zyrtec -- were made by Johnson & Johnson, a division of McNeil Consumer Healthcare, and come in a liquid form.
Could I have overdosed my child without knowing it?
The risk is small. Of most concern is Tylenol, which when taken in large amounts over long periods can cause liver problems. Tylenol can be deadly when it is not taken appropriately, but you have to take a significant amount to have a problem. Parents don't want to give acetaminophen, the generic equivalent of Tylenol, round-the-clock.
What signs should parents watch for if their children have taken any of the products routinely?
If they start acting unwell or show signs of jaundice such as yellowing of the skin or if their level of consciousness is altered, check it out right away.
What do I do if I gave my children some of the recalled medication?
Unless they are showing symptoms, there is no reason to do anything.
If I think my child is having a side effect, whom should I notify?
Contact your physician first and get treatment. To report adverse reactions, visit www.fda.gov/medwatch.
What should I do if my child has a fever or allergies and needs one of the recalled medications?
Switch to generics. They are not affected by the recall and are safe to take. Only products by McNeil have been recalled. The generic equivalents are as follows:
Cetirizine -- Zyrtec
Diphenhydramine -- Benadryl
Acetaminophen -- Tylenol
Ibuprofen -- Motrin
Can I give my child a lower dosage of adult-strength Tylenol or Motrin?
No. Children's medications are formulated based on age and weight. Don't cut adult tablets in half or estimate how much a child's dose of an adult's medication might be.
Can consumers get a refund for the recalled drugs?
Yes. Consumers can receive either a refund for the average retail price or a coupon for a free replacement when the medication becomes available. Go to www.mcneilproductrecall.com.
Where can I get more information?
Visit www.mcneilproductrecall.com for a complete list of recalled products.
Jan Jarvis, 817-390-7664