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PediaCare Added to Medicine Recall

Parents advised to substitute generic versions of liquid Tylenol, Motrin, Zyrtec and Benadryl. Refunds are available.

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.

Brand Name Active Ingredient
Tylenol acetaminophen
Motrin ibuprofen
Benadryl dyphen-
hydramine
Zyrtec cetirizine

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.

Recalled McNeil Children's Medications
Product

National Drug Code (can be found on label)

Tylenol Infants’ Drops
Concentrated Tylenol Infants’ Drops 1 Oz. Grape
50580-144-01
Concentrated Tylenol Infants’ Drops 0.5 Oz. Grape*
50580-144-15
Concentrated Tylenol Infants’ Drops 1 Oz. Cherry Dye Free
50580-167-01
Concentrated Tylenol Infants’ Drops 0.5 Oz. Cherry
50580-143-15
Concentrated Tylenol Infants’ Drops 1 Oz. Cherry
50580-143-30
Concentrated Tylenol Infants’ Drops 0.5 Oz. Grape - Hospital
50580-144-18
Concentrated Tylenol Infants’ Drops 0.25 Oz. Grape - Sample
50580-144-40
Children’s Tylenol Suspensions
Children’s Tylenol Suspension 2 Oz. Cherry Blast
50580-123-02
Children’s Tylenol Suspension 4 Oz. Cherry Blast
50580-123-04
Children’s Tylenol Dye-Free Suspension 4 Oz. Cherry
50580-166-04
Children’s Tylenol Suspension 4 Oz. Grape Splash
50580-296-04
Children’s Tylenol Suspension 4 Oz. Bubblegum
50580-407-04
Children’s Tylenol Suspension 4 Oz. Very Berry Strawberry
50580-493-04
Children’s Tylenol Suspension 1 Oz. Cherry Blast – Sample
50580-123-01
Children’s Tylenol Suspension 4 Oz. Cherry Blast – Hospital
50580-123-03
Children’s Tylenol Plus Suspensions
Children’s Tylenol Plus Suspension 4 Oz. Cough & Sore Throat Cherry
50580-247-04
Children’s Tylenol Plus Suspension 4 Oz. Cough & Runny Nose Cherry
50580-249-04
Children’s Tylenol Plus Dye-Free Suspension 4 Oz. Cold & Stuffy Nose Grape
50580-253-04
Children’s Tylenol Plus Dye-Free Suspension 4 Oz. Cold & Cough Grape
50580-254-04
Children’s Tylenol Plus Dye-Free Suspension 4 Oz. Multi-Symptom Cold Grape
50580-255-04
Children’s Tylenol Plus Suspension 4 Oz. Flu Bubblegum
50580-386-04
Children’s Tylenol Plus Suspension 4 Oz. Cold Grape
50580-387-04
Children’s Tylenol Plus Suspension 4 Oz. Cold & Allergy Bubblegum
50580-390-04
Children’s Tylenol Plus Suspension 4 Oz. Multi-Symptom Cold Grape
50580-391-04
Motrin Infants’ Drops
Concentrated Motrin Infants’ Drops 1 Oz. Berry Dye Free
50580-198-01
Concentrated Motrin Infants’ Drops 0.5 Oz. Berry Dye Free
50580-198-15
Concentrated Motrin Infants’ Drops 0.5 Oz. Berry*
50580-100-15
Children’s Motrin Suspensions
Children’s Motrin Suspension 4 Oz. Berry Dye Free
50580-184-04
Children’s Motrin Suspension 2 Oz. Berry
50580-601-02
Children’s Motrin Suspension 4 Oz. Berry
50580-601-04
Children’s Motrin Suspension 4 Oz. Tropical Punch
50580-215-04
Children’s Motrin Suspension 4 Oz. Grape
50580-603-04
Children’s Motrin Suspension 4 Oz. Bubblegum
50580-604-04
Children’s Motrin Suspension 1 Oz. Grape Sample
50580-603-01
Children’s Motrin Suspension 1 Oz. Bubblegum Sample
50580-604-01
Children’s Motrin Suspension 1 Oz. Berry Sample
50580-601-01
Children’s Motrin Suspension 4 Oz. Berry Hospital
50580-601-50
Children’s Motrin Suspension 4 Oz. Cold Berry
50580-902-04
Children’s Zyrtec  Liquids In Bottles
Children’s Zyrtec  4 Oz. Bubblegum Syrup
50580-721-04
Children’s Zyrtec Dye Free 4 Oz. Grape Syrup
50580-730-04
Children’s Zyrtec Sugar-Free Dye-Free 0.5 Oz. Grape
50580-730-15
Children’s Zyrtec Sugar-Free Dye-Free 0.5 Oz. Bubblegum
50580-721-15
Children’s Zyrtec Sugar-Free Dye-Free 2 X 4 Oz. Bubblegum Liquid
50580-721-08
Children's Benadryl Allergy Liquids In Bottles
Children's Benadryl Allergy 4 Oz. Bubblegumed Liquid
50580-535-04

* Concentrated Tylenol Infants’ Drops 0.5 Oz. Grape is also included in Johnson's Baby Relief Kit.
*Concentrated Motrin Infants’ Drops 0.5 Oz. Berry is also included in Johnson's Baby Relief Kit.

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