PediaCare Added to Medicine Recall

Experts advise parents to substitute generic medications for some 40 liquid children’s medications that were recalled April 30. The recall involves liquid versions of children’s Tylenol, Motrin, Zyrtec and Benadryl manufactured by McNeil Consumer Healthcare, a Fort Washington, PA arm of Johnson & Johnson.

Four additional children’s medications — PediaCare Multi-Symptom Cold, PediaCare Long Acting Cough, PediaCare Decongestant and PediaCare Allergy and Cold — were recalled May 28. They were manufactured for Blacksmith Brands, Inc. at the Fort Washington plant, where Johnson & Johnson has suspended production pending an overhaul of quality control procedures.

 The Food and Drug Administration asked McNeil to recall its medications after an inspection revealed some of the medications had too much or too little of their active ingredient. Others had impurities or "tiny particles," according to the FDA, which says "the potential for serious medical problems (from the recalled medications) is remote."

The FDA subsequently released a blistering report that resulted from an April 30 inspection of McNeil’s Fort Washington plant. "Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity," said one of the report’s many critical findings.

The FDA said McNeil did not take "corrective and prevention action" despite receiving 46 consumer complaints beginning in June 2009 reporting foreign materials and specks in its medications. The agency said it is considering a wide range of penalties, including possible criminal action.

How to get a refund     |     List of the recalled medications

 “We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product,” said U.S. Commissioner of Food and Drugs Margaret A. Hamburg, MD. "If your child exhibits any unexpected symptoms after use of any of the recalled products, contact your health care professional." She suggested parents use generic versions of the recalled medications.

Daniel A. Hussar, PhD, a professor of pharmacy at the University of the Sciences in Philadelphia, goes farther. "Rather than trying to determine if one of these products is on the list, I advise parents to just stop using it and find a generic formulation that’s equivalent," he suggests.

But how can parents know if a generic version is the same as the medication they’ve been using? "Ask the pharmacist," says Dr. Hussar. "The pharmacist is an excellent resource who can confirm that the product is exactly the same, or identify a product that would be the equivalent of the one that was used."  Many supermarkets that sell generic medications do not have pharmacists, however. "In this situation, use a pharmacy," he advises.

Dr. Hussar notes that generic versions are usually substantially less expensive than brand name, over-the-counter medications such as those recalled. So why would anyone buy the brand name version? "Some people just have more confidence in a brand name product," he says. "It reflects the power of advertising. What’s ironic is that this recall involves quality control at one of the most admired names — McNeil and Johnson & Johnson — not the companies marketing the generic products.

The recall is McNeil’s fourth in the past seven months. In January, McNeil recalled Tylenol and other medications manufactured in a Puerto Rican facility because they emitted a musty odor.

McNeil is offering two options for consumers who have purchased products affected by this recall: a refund for the average retail price of the product or a coupon for free replacements when the product becomes available again. Click here to request a refund or coupon.

To process your refund or coupon you will need the NDC number and Lot number from the product that has been recalled. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label, usually placed vertically.

For more information about the recalled PediaCare items, consumers can call 888-474-3099 or visit www.blacksmithbrands.com.