Johnson & Johnson is recalling its entire U.S. supply of infant Tylenol Oral Suspension 1 oz. Grape, after parents complained about problems with its new dosing syringe.
The recall involves about 574,000 bottles of the grape –flavored liquid Tylenol for children younger than 2 years old.
Parents have reported that the Tylenol “SimpleMeasure™” dosing system is flawed and difficult to use.
“SimpleMeasure™” includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.
When parents inserted a syringe into the bottle, some accidentally pushed a protective cover inside.
To date, J&J has received 17 complaints, company spokeswoman Bonnie Jacobs said.
No serious side effects from the infant Tylenol have been reported.
A J & J spokesperson said the risk of such problems are "remote. "
The recall is from stores and wholesalers; consumers can still use the product provided that the protective cover at the top of the bottle remains in place, J&J said.
The recall does not affect Tylenol for children 2 years and older, for which J&J also introduced a new but different design.
The Tylenol liquid formula for infants will be off the shelves for an indefinite time.
"We are looking for various alternatives for the redesign," Jacobs said. "Once we have reviewed those options, we will set a timeline for the product to return." The product was manufactured to specifications, so the company is investigating why it was not performing as expected, Jacobs said.
The new syringe was developed in response to calls from drug safety advocates and the FDA to provide more precise dosing systems for liquid children's medications, after studies showed that over- and under-dosing were common with spoons and cups.
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 www.tylenol.com or contacting McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.tylenol.com for additional information.
Sources: http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_8.inc ... http://www.msnbc.msn.com/id/46427423/ns/health-childrens_health/t/infant-tylenol-recalled-over-flaw-dosing-system/#.T0Eoz5gzJnY
