Company Issues Nationwide Recall Of Infants’ Tylenol

DETROIT (WWJ/AP) – Recall-plagued Johnson & Johnson is pulling all infant Tylenol off the U.S. market because some parents have had problems with redesigned bottles, introduced three months ago, that the company touted as a big safety improvement to make measuring doses easier.

J&J’s McNeil Consumer Healthcare unit, which has had about 25 product recalls since September 2009, said Friday that it is recalling all 574,000 bottles of grape-flavored, liquidInfants’ Tylenol Oral Suspension from stores nationwide.

The infant Tylenol bottle comes with a plastic syringe that’s to be inserted into the flow restrictor at the top to help measure the right dose. The syringe has an opening in the tip but no needle. Consumers are to insert the tip of the syringe into the flow restrictor, turn the bottle upside down and then draw out the right dose using the milliliter markings on the syringe. That’s then squirted into the baby’s mouth.

Beaumont Hospital Chief of Pediatric Allergy, Immunology and Pulmonology, Dr. Devang Doshi explained why the product was recalled.

“They were trying to make it very easy for patients to be able to drop the proper dose with the syringe and plunger device, and what they found is many consumers were having difficulty with getting a dose that was proper and the plunger was falling in the bottle,” said Doshi.

McNeil said the recall was a precaution, after receiving a small number of complaints from consumers. No adverse events associated with this action have been reported to date and the risk of a serious adverse medical event is remote.

The full recall product list include Infants’ Tylenol Oral Suspension 1 oz. Grape, with lot codes BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, or BJL2U00. The UPC code is 300450122308.

If you have the infant Tylenol and the plunger works, Doshi said you can use it. Otherwise, he said you may want to return it to the store for a refund and replace it with a generic brand of acetaminophen.

“There’s always generic options that are available over the counter, and you can always check with the pharmacist at the drugstore … the generic name for Tylenol is acetaminophen and then, you know, as with all medications, it’s very important to check with your local pediatrician and to get the appropriate dose based on your child’s weight to figure out how much to give,” said Doshi.

If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. Consumers can request a refund by visiting or contacting McNeil at 1-888-222-6036.

Doshi said it may be months before Infant Tylenol is back on store shelves because they’ll have to re-design the bottle.

“This is obviously a very difficult time, you know, especially where we are now seeing a lot of cold and flu activity in the Metro Detroit area and for them to recall Tylenol when we really need it the most is going to be very challenging,” said Doshi.

TM and © Copyright 2011 CBS Radio Inc. and its relevant subsidiaries. CBS RADIO and EYE Logo TM and Copyright 2011 CBS Broadcasting Inc. Used under license. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed. The Associated Press contributed to this report.

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