Johnson & Johnson's McNeil unit recalls Children's Tylenol over labeling confusion

Friday, June 3rd 2005, 11:08 am

By: News On 6

FORT WASHINGTON, Pa. (AP) _ McNeil Consumer & Specialty Pharmaceuticals, a unit of health care products company Johnson & Johnson Inc., is recalling certain lots of Children's Tylenol because of confusing packaging that could result in overdosing.

The company said Friday it is recalling all lots and all flavors of 80 milligram-strength Children's Tylenol Meltaways packaged in bottles and blisters, 80 milligram-strength Children's Tylenol SoftChews packaged in blisters, and 160 milligram-strength Jr. Tylenol Meltaways packaged in blisters. The recall affects only SoftChews and Meltaways versions of the product.

Taking more than the prescribed dosage of acetaminophen, the active ingredient in Tylenol, may cause liver damage when taken for three or more days.

In 80 milligram-strength products, the recall was triggered by concerns that blister packs containing two pills in each compartment would lead some consumers to believe that the two tablets contained a total of 80 milligrams of acetaminophen, when each tablet contains 80 milligrams.

McNeil spokeswoman Kathy Fallon said in an interview that the company eliminated the double-pill blister cavity design for a single pill cavity design in the first quarter.

As for bottled products and the 160 milligram-strength product, the company said that labeling on the front panel of the carton could confuse consumers on proper dosages. The spokeswoman said that McNeil was changing wording on the front of the package to say that each ``tablet'' contains the given strength of acetaminophen rather than each ``dose.''

Fallon said the company was alerted to the possible confusion after receiving calls from consumers concerning proper dosing. She said she didn't know how many units were affected by the recall, or how long it would take to complete. She said the company had no reports of adverse events related to dosing.

Fallon said the company has notified the Food and Drug Administration of the voluntary recall and that it will launch a campaign to alert consumers about proper dosages.