All Infants’ Tylenol Recalled Following Complaints Of Faulty Bottle

More Tylenol is being recalled. This time, the recall is for all Infants’ Tylenol, following complaints about a new bottle design that was supposed to make dosage easier for parents and caregivers, said the U.S. Food and Drug Administration (FDA).

McNeil Consumer Healthcare, a Division of McNeil-PPC, Inc., a unit of Johnson & Johnson, is recalling, at the wholesale and retail levels, seven lots of its Infants’ Tylenol Oral Suspension. Some 574,000 bottles of the 1-ounce grape-flavored medication, distributed nationwide in the United States, are involved in the recall. Infants’ Tylenol is an over-the-counter (OTC) product indicated as a pain reliever and fever reducer.

McNeil received a small number of complaints from consumers who reported difficulty using the Infants’ Tylenol SimpleMeasure dosing system, which includes a dosing syringe that 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. According to the Christian Science Monitor, 17 parents or caregivers complained about the faulty protective covers.

Children’s Tylenol products are intended for children two years of age and older and continue to remain available. To date. no adverse events connected to this recall have been reported and the risk of a serious adverse medical event is considered remote.

The firm advises consumers that they can continue to use Infants’ Tylenol as long as the flow restrictor at the top of the bottle remains in place; however, 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, toll-free, at 1.888.222.6036, Monday through Friday, from 8:00 a.m. to 8:00 p.m., Eastern Time (ET), and Saturday and Sunday, from 9:00 a.m. to 5:00 p.m. ET.

The recall involves all Infants’ Tylenol Oral Suspension, 1-ounce, grape, and includes UPC 300450122308 and lot numbers BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, and BJL2U00. The Christian Science Monitor reported that Johnson & Johnson is pulling all Infants’ Tylenol off the U.S. market over the newly designed bottle issues, which was introduced three months ago and advertised as a major safety improvement.

Since September 2009, McNeil’s Consumer Healthcare unit has issued about 25 product recalls. McNeil spokeswoman Bonnie Jacobs said it was too early to discuss when the Infants’ Tylenol will return to the market. “We are looking at various alternatives for the redesign of the dosing system and will set a timeline … once we’ve reviewed all the options,” she said, wrote the Christian Science Monitor.

Johnson & Johnson’s recently issued another in a series of recalls over smelly drugs, pulling about 60,912 bottles of its musty smelling Extra-Strength Tylenol caplets in the United States. The Wall Street Journal pointed out that these and other recalls cost the drug giant some $900 million dollars, just in sales and just in 2010. Recalls for musty odors, sterility issues, and other problems involved 200 million bottles of medications including the company’s Ortho-McNeil-Janssen Pharmaceuticals division’s prefilled Invega Sustenna syringe; its Ethicon unit’s surgical drainage products; two DePuy hip replacement implants, sold by its DePuy Orthopaedics unit; insulin pump cartridges made by its Animas unit; 1-Day Acuvue TruEye contact lenses; and Simponi injection pens, to name just some.

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