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Drug Recalls

What To Do When the FDA Recalls Drugs

By

Updated January 05, 2011

Written or reviewed by a board-certified physician. See About.com's Medical Review Board.

Parents are often familiar with and look out for food recalls or product recalls, such as car seat recalls and crib recalls, but often overlook drug recalls.

Drug Recalls

Why might a company issue a drug recall?

Sometimes it is simply because the dosing instructions are confusing, which can lead to a parent giving the wrong dose of the medication to their child, but there is nothing actually wrong with the drug. This is what happened with the recall of Children's Tylenol Meltaways and Tylenol Softchews in 2005.

A company might also issue a drug recall because something is wrong with the dosing tool that came with the drug, like a medicine dropper or dosing cup. This is what led to the recall of all lots of concentrated infant's drops made by the Perrigo Company in 2007. The dosing syringe that came with this cold medicine only had a 1.6ml mark, while most drugs like this were given to younger children at doses of 0.4ml and 0.8ml.

A drug recall might also be issued because the drug or an ingredient in the drug is thought to no longer be safe. This is what occurred back in 2000 when all over-the-counter cold medicines containing phenylpropanolamine (PPA) were recalled because the FDA issued a public health advisory associating PPA with an increased risk of hemorrhagic stroke, or bleeding into the brain.

Lastly, a drug recall might be issued because the drug is contaminated, has an improper dose of the active ingredient, or because the package contains the wrong medication (for example, McNeil recalled Children's Motrin Chewable Tablets in 2005 because the package actually contained Tylenol 8-Hour extended release Geltabs).

Another Drug Recall - What Should You Do?

Whatever the reason for the drug recall, it is important that parents realize that they have the recalled drug in their home and stop using it as soon as possible.

Parents should also:

  • See their pediatrician if they think their child is having any active symptoms from a medication on a drug recall list.

  • Watch for and report any side effects their child may have had from the recalled drug to the FDA's MedWatch Adverse Event Reporting Program.

  • Find an alternative medication to give their child, which might include a generic version of the drug, an alternate brand-name version, or a different class of medication all together.

  • Get a refund or rebate coupon from the manufacturer that issued the drug recall or from the store where they bought the recalled drug.

  • Never give their child an adult version of a medication simply because the infant or child strength drug is on a drug recall list.

  • Regularly watch for new drug recalls and drug warnings from the FDA.

  • Inspect any drugs they give their kids for signs of tampering or contamination, including unusual odors, colors, or particles in the drug.

  • Get rid of leftover or half-used prescriptions and any expired drugs that you may have in your medicine cabinet, which may help make it less likely that you might give your child a recalled drug.

And while you should get rid of the recalled drug, never throw them in the trash or simply flush them down the toilet. Instead, ask your pharmacist or local hazardous waste disposal site about safe disposal options in your area. Kids can get into medicines you throw into the trash, and medicines you flush end up in our groundwater.

Even if you decide to keep the bottle or package of a medication on a drug recall list, you should properly dispose of the actual recalled drug to make sure that you don't accidentally give it to your child.

Recent Drug Recalls

Recent drug recalls, including prescription drugs and over-the-counter drugs that you may have in your home, have included:

  • November 2010: Twelve Mylanta liquid products.

  • October 2010: Hyland's Teething Tablets.

  • November 2010: McNeil Consumer Healthcare has recalled all lots of Children's Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors, all lots of Junior Strength Motrin Caplets, in 24 count packages, and three types of Tylenol Cold Multi-Symptom liquid products.

  • July 2010: An expanded Tylenol recall was issued by McNeil Consumer Healthcare to now include 21 lots of Children's TYLENOL Meltaways Bubblegum and certain forms of Benadryl Allergy Ultratabs, Motrin IB, Tylenol Extra Strength, and Tylenol PM.

  • May 2010: A Pediacare recall was issued because four of their cold and allergy products were made for Blacksmith Brands by McNeil Consumer Healthcare at the same manufacturing plant where the recalled Tylenol products were made and which was recently shut down.

  • May 2010: Tylenol Recall 2010 included a recall of certain forms of infant and children's Tylenol, Motrin, Benadryl, and Zyrtec manufactured by McNeil Consumer Healthcare.

  • January 2010: Multiple forms of Children's Motrin, Children's Tylenol, Benadryl, Extra Strength Tylenol, Motrin IB, Regular Strength Tylenol, Rolaids, Simply Sleep, St. Joseph Aspirin, Tylenol 8 Hour, Tylenol Arthritis, and Tylenol PM that were manufactured by McNeil Consumer Healthcare were recalled because of an "unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events."

Fortunately, unlike food recalls or other product recalls, we rarely hear reports that a drug recall has led to any serious medical problems in a child. And hopefully new safety guidelines that are supposed to be coming from the FDA will keep it that way and prevent any more of these types of drug recalls in the future.

Sources:

FDA Recall - Firm Press Release. McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji. Accessed May 2010.

FDA Recall - Firm Press Release. Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine 20mg Tablets, Lot number 311756. Accessed May 2010.

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